MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ELITE MODULAR HD 32MM +3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	9627-35-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
Revision of pinnacle insert.Insert was dislocated from shell with obvious wear.Likely cause impingement.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Visual examination of the provided x-ray images and photographs confirmed the reported event, and found the head to be worn.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : a manufacturing record evaluation was performed for the finished device d12042470, and no non-conformances/manufacturing irregularities were identified.

• Brand Name: ELITE MODULAR HD 32MM +3
• Common Device Name: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11872407
• Report Number: 1818910-2021-11031
• Device Sequence Number: 3179149
• Product Code: JDI
• UDI-Device Identifier: 10603295244134
• UDI-Public: 10603295244134
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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: 9627-35-000
• Device Catalogue Number: 962735000
• Device Lot Number: D12042470
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/04/2021
• 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: C STEM VOID CENTALIZER 12 DM; C-STEM SZ3 HIGH OFFSET; ELITE MODULAR HD 32MM +3; HARDINGE CEMENT RESTRICTOR; PINN MAR +4 10D 32IDX52OD; PINN SECTOR HA ACET CUP 52MM; C STEM VOID CENTALIZER 12 DM; C-STEM SZ3 HIGH OFFSET; ELITE MODULAR HD 32MM +3; HARDINGE CEMENT RESTRICTOR; PINN MAR +4 10D 32IDX52OD; PINN SECTOR HA ACET CUP 52 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 99