ARTICULEZE M HEAD 36MM +1.5

Adverse Event reported on 1/30/2014

Device Attributes
AttributeValue
Manufacturer8010379 DEPUY INTL., LTD.
Brand NameARTICULEZE M HEAD 36MM +1.5
Device TypeHIP FEMORAL HEAD
Product CodeJDI
Model Number
Catalog Number136551000
Device Operator0HP
8010379 DEPUY INTL., LTD. ARTICULEZE M HEAD 36MM +1.5 HIP FEMORAL HEAD   Back to Search Results
Catalog Number 136551000
Event Date 01/02/2014
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Examination of the reported devices was not possible as they were not returned. The reason for revision has not been provided and a revision has not been confirmed. A search of the complaints databases finds one other report against the 1787381 corail stem lot code. The device was non-contributing to the report. The dhr analysis of the batch provided shows an initial conformance of this product with regards to its specification. For this batch, there was no deviation or non-conformance. A search of the complaints databases finds no other reports against the remaining product/lot code combinations since their release to distribution. The investigation can draw no conclusions with the information provided. Based on the inability to determine a root cause, a need for corrective action is 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.

 
Event Description

Possible revision of pinnacle mom implants. Reason not provided, revision date not confirmed.

 
Manufacturer Narrative

Additional narrative: this complaint is still under investigation. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Source: FDA