Adverse Event reported on 10/22/2013

Device Attributes
ManufacturerDEPUY INTL., LTD. ? REG. # 8010379
Product CodeJDI
Model Number
Catalog Number136554000
Device Operator0HP
DEPUY INTL., LTD. ¿ REG. # 8010379 ARTICULEZE M HEAD 36MM +12 FEMORAL HEAD Back to Search Results
Catalog Number 136554000
Event Date 12/09/2011
Event Type  Injury  
Manufacturer Narrative

The devices associated with this report were not returned. A review of the device history records for the xvp79 lot code did not reveal any related manufacturing deviations or anomalies. A previous review of the device history records for the 1973254 lot code did not reveal any related manufacturing deviations or anomalies. A complaint database search finds no other reported incidents against the remaining product and lot combinations. The investigation could not verify or identify any product contribution to the reported event with the information provided. Based on the inability to identify root cause, the need for corrective action was not indicated.

Manufacturer Narrative

The investigation is ongoing. Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4). Reason for original complaint. - litigation alleges: in 2002, patient was implanted with a depuy pinnacle mom implant in her right hip. Patient suffered debilitating pain, swelling, inflammation, infection, damage to surrounding bone and tissue, and lack of mobility. In (b)(6) 2005, patient was revised and implanted with a new pinnacle mom device. In 2010, the new implant began slipping out of the socket causing intense pain, discomfort, and the inability to walk without assistance. Patient is unable to be revised a second time due to too little bone structure remaining. Doi: 2002 - dor: (b)(6) 2005 (right hip; first implantation); doi: (b)(6) 2005 - dor: none (right hip; second implantation). Patient is a resident of (b)(6). Update: (b)(4) 2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified. Originally implanted (b)(6) 2002, revised (b)(6) 2005 because of instability. Records are available for further review.

Search Alerts/Recalls
Source: FDA