MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DUR OPT LPW POLY INS 28/52; DURALOC OPTION IMPLANTS : HIP POLY ACETABULAR LINERS

Model Number	1599-23-052
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary, no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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
Revision surgery planned for the patient needing to preserve cup that is in situ currently and promote bone preservation - need replacement liner for the cup.Note from sales rep: the patient needs a liner replacement for the duraloc option cup that was implanted in 2004.At the date of operation, the patient was (b)(6) and the procedure was a revision operation.The patient has not presented any adverse symptoms and there is no alleged deficiency with the depuy product.The liner needs to be replaced after identifying some wear to the liner as could be expected.

• Brand Name: DUR OPT LPW POLY INS 28/52
• 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
• MDR Report Key: 10010571
• Report Number: 1818910-2020-11489
• Device Sequence Number: 11399546
• Product Code: LPH
• UDI-Device Identifier: 10603295065654
• UDI-Public: 10603295065654
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K040544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1599-23-052
• Device Catalogue Number: 159923052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR