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

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 334638501
• Report Number: 1818910-2024-02449
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295065678
• UDI-Public: 10603295065678
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 80 KG