MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR MAR NEUT LNR 32IDX62OD; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Model Number	1220-32-062
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2021
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 patient had liner wear.Surgeon removed duraloc liner and replaced with a new liner.The taper head was removed and replaced with a new head.The locking ring was also replaced.Cup and stem remained implanted.Doi: unknown; dor: (b)(6) 2021 (left hip).
Event or Problem Description
Additional information received indicated that the patient was not experiencing any symptoms.The surgeon just wanted to replace the device before any further wear is experienced.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: b1 (product problem), b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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.Device history lot : a device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: DUR MAR NEUT LNR 32IDX62OD
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11499181
• Report Number: 1818910-2021-05246
• Device Sequence Number: 2843510
• Product Code: LPH
• UDI-Device Identifier: 10603295015505
• UDI-Public: 10603295015505
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1220-32-062
• Device Catalogue Number: 122032062
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/18/2021; 04/08/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/05/2021; 04/09/2021
• 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: DUR DYNAMIC LOCK RING 60 OR 72; TOTAL HIP BALL 32MM +11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR