MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN LNR CON +4 10D 32IDX58OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Catalog Number	121832758
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2018
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
Clinical adverse event received for abnormal x-ray - polywear.Event is not serious and is considered mild.Event is definitely related to both device and procedure.Date of implantation: (b)(6) 2012 (cup, liner, screws -- stem & head unknown).Date of event: (b)(6) 2018.(left hip).
Additional Manufacturer Narrative
Product complaint #: (b)(4).The previous device code (naturally worn) is being retracted as it was further identified that there was no poly wear based on xray review done.

• Brand Name: PINN LNR CON +4 10D 32IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9187513
• Report Number: 1818910-2019-109763
• Device Sequence Number: 2819688
• Product Code: KWZ
• UDI-Device Identifier: 10603295012023
• UDI-Public: 10603295012023
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K043058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121832758
• Device Lot Number: D59JV1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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: PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN MULTIHOLE W/GRIPTION 58MM
• Patient Age: 72 YR
• Patient Weight: 109