ARTICULEZE M HEAD 36MM -2

Adverse Event reported on 1/9/2014

Device Attributes
AttributeValue
Manufacturer8010379 DEPUY INTL., LTD.
Brand NameARTICULEZE M HEAD 36MM -2
Device TypeFEMORAL HEAD
Product CodeJDI
Model Number
Catalog Number136550000
Device Operator0HP
8010379 DEPUY INTL., LTD. ARTICULEZE M HEAD 36MM -2 FEMORAL HEAD Back to Search Results
Catalog Number 136550000
Event Type  Injury  
Event Description

Litigation papers allege: on or about (b)(6) 2008, patient was implanted with a depuy pinnacle mom hip on his right side. In 2010, patient began to suffer symptoms including, but not limited to pain, weakness, and difficulty with even simple daily activities. Update: (b)(4) 2012, pfs was received from legal, medical records were received from legal, and part/lot information was identified. Records are available for further review.

 
Manufacturer Narrative

New etq record created in order to update etq (legacy system) complaint number (b)(4). Reason for original complaint. - litigation papers allege: on or about december 9, 2008, patient was implanted with a depuy pinnacle mom hip on his right side. In 2010, patient began to suffer symptoms including, but not limited to pain, weakness, and difficulty with even simple daily activities. Doi: (b)(6) 2008 - dor: unk (right side). Patient is a resident of (b)(6). Update: 11/15/2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified. Records are available for further review. Update rec'd 11/15/2012- pfs and medical records received. Lot number being updated for liner. There is no new additional information that would affect the existing mdr decision. The complaint was updated on: 10/23/2014. (b)(4). No device associated with this report was received for examination. Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
Search Alerts/Recalls
Source: FDA