MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DUR OPT LPW POLY INS 28/58,60; DURALOC OPTION IMPLANTS : HIP POLY ACETABULAR LINERS

Catalog Number	159923058
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon is ordering a patient specific hip-inlay for a planned revision because of normal and expected pe-wear left side.There has been no allegation of any product deficiency.Doi: 2004.Dor: planned as soon as patient specific implant will be manufactured by depuy in spring 2024.Left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Dhr review : product description: dur opt lpw poly ins 28/58,60.Product code: 159923058.Lot number: 1177167.1) quantity manufactured: (b)(4).2) date of manufacture: 2/26/2004.3) any anomalies or deviations identified in dhr: no.4) expiry date: 2/19/2009.5) ifu reference: ifu-0902-00-825.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : dhr review : product description: dur opt lpw poly ins 28/58,60.Product code: 159923058.Lot number: 1177167.1) quantity manufactured: (b)(4).2) date of manufacture: 2/26/2004.3) any anomalies or deviations identified in dhr: no.4) expiry date: 2/19/2009.5) ifu reference: ifu-0902-00-825.

• Brand Name: DUR OPT LPW POLY INS 28/58,60
• Common Device Name: DURALOC OPTION IMPLANTS : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18649905
• Report Number: 1818910-2024-02449
• Device Sequence Number: 7111974
• Product Code: LPH
• UDI-Device Identifier: 10603295065678
• UDI-Public: 10603295065678
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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 Expiration Date: 02/19/2009
• Device Catalogue Number: 159923058
• Device Lot Number: 1177167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2004
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 80 KG