MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR LIP LNR 32IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-260
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/30/2020
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
Washout of a potential infected thr.Primary procedure was don on (b)(6) 2009.Patient presented with severe pain and discomfort.Blood showed increase with white cells and surgeon suspected an infection.No grossly contaminated infected tissue could be seen or was super obvious.Multiple specimens taken intra-op for testing.Femoral head and poly liner removed.Massive washout completed and new head and liner were inserted into right 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, post market surveillance, 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.Device history lot: the device was implanted approximately 11 years prior a need for revision surgery.It is not suspected any error in device manufacture or sterile processing was the root cause for the problems reported.A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN MAR LIP LNR 32IDX60OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11332102
• Report Number: 1818910-2021-03051
• Device Sequence Number: 16421999
• Product Code: LPH
• UDI-Device Identifier: 10603295014225
• UDI-Public: 10603295014225
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2021

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: 1219-32-260
• Device Catalogue Number: 121932260
• Device Lot Number: C2BDA1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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: ARTICUL/EZE BALL 32 +5 BR; PINN MAR LIP LNR 32IDX60OD; ARTICUL/EZE BALL 32 +5 BR; PINN MAR LIP LNR 32IDX60OD
• Outcome Attributed to Adverse Event: Required Intervention