MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 P.F.C.* 28MM HEAD +5 MM; PFC FEMORAL HEADS (10/12) : HIP METAL FEMORAL HEADS

Model Number	85-3834
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that the surgeon did a left hip revision on (b)(6) 2020, at (b)(6) due to instability.The patient had original surgery around 20 years ago at (b)(6).The patient had a pinnacle 56 cup with a pfc 3m stem and a 28mm +5 pfc head, +4 10 deg 28id liner.The 28 pfc head plus 5 was removed-and the liner was removed and replaced with depuy parts.No further info is known or available at this time.To answer the question below-nothing was broken in surgery and therefore no instrumentation was removed from the patient.Doi: 20 years ago, dor: (b)(6) 2020, left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Common Device Name: PFC FEMORAL HEADS (10/12) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10615321
• Report Number: 1818910-2020-21437
• Device Sequence Number: 3818888
• Product Code: KWY
• UDI-Device Identifier: 10603295207610
• UDI-Public: 10603295207610
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K893872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2020

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: 85-3834
• Device Catalogue Number: 853834
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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: PFC 3M STEM; PINN MAR +4 10D 28IDX56OD; PINNACLE 56; PFC 3M STEM; PINN MAR +4 10D 28IDX56OD; PINNACLE 56
• Outcome Attributed to Adverse Event: Required Intervention