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

Model Number	1599-23-058
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Surgeon is ordering a patient specific pe inlay for a planned revision because of normal and expected pe-wear left side.Doi: (b)(6) 2003.Dor: planned as soon as patient specific implant will be manufactured by depuy in 2023.There has been no allegation of any product deficiency.
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 : a manufacturing record evaluation was performed for the finished device 159923058, lot 1058855, and no non-conformances / manufacturing irregularities were identified.1) quantity manufactured: (b)(4).2) date of manufacture: 31-oct-2002.3) any anomalies or deviations identified in dhr: no anomalies or deviations identified.4) expiry date: 30-oct-2007.5) ifu reference: ifu-000669129 h4.

• 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15968525
• Report Number: 1818910-2022-25188
• Device Sequence Number: 14687012
• 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: 2003
• 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): 12/13/2022

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: 1599-23-058
• Device Catalogue Number: 159923058
• Device Lot Number: 1058855
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2002
• 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: 83 YR
• Patient Sex: Male