MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 62MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-22-062
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/26/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Asr re-revision.Information received from crawfords.Asr revised (b)(6) 2012.Revised to pinnacle ceramic.Pinnacle ceramic products revised due to dislocation (not arising from traumatic event).Hip(s) to be revised: left doi: (b)(6) 2012 - dor: (b)(6) 2012 (left hip).
Additional Manufacturer Narrative
Product complaint (b)(4).Corrected: b4 (alert date).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Corrected: b4 (alert date).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Corrected h6 patient code: no code available (3191) from the initial medwatch to capture patient harm surgical intervention.

• Brand Name: PINNACLE SECTOR II CUP 62MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10514753
• Report Number: 1818910-2020-19766
• Device Sequence Number: 16907928
• Product Code: LPH
• UDI-Device Identifier: 10603295009870
• UDI-Public: 10603295009870
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/29/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1217-22-062
• Device Catalogue Number: 121722062
• Device Lot Number: 110679
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 08/18/2020; 08/18/2020; 10/05/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 09/10/2020; 09/10/2020; 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DLT TS CER HD 12/14 36MM +12; EA DELTA CER INSERT 36IDX52OD; DLT TS CER HD 12/14 36MM +12; EA DELTA CER INSERT 36IDX52OD
• Outcome Attributed to Adverse Event: Required Intervention