MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP DURALOC

Catalog Number UNK HIP ACETABULAR CUP DURALOC

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 04/24/2023

Event Type  Injury  

Event Description

It was reported that the patient had hip replaced over 20 years ago where patient had a hps 2 stem and a duraloc acetabular cup.Patient recently had hip revised by an orthopedic surgeon at a different facility for a worn out duraloc poly liner.The surgeon explanted the femoral hip ball and duraloc poly liner because of wear and cemented a stryker acetabular liner into the duraloc cup and implanted a depuy ts ceramic hip ball.The patient dislocated days after revision surgery and came to hospital where surgeon was consulted.Doctor revised hip and discovered the stryker liner that was cemented into the duraloc cup had come loose and was out of the cup which resulted in the dislocation of the hip construct.Surgeon explanted the duraloc cup and femoral hip ball and implanted a zimmer acetabular cup with a dual mobility liner and a depuy ts ceramic hip ball.The cat # & lot # for the hps 2 stem that was left insitu is unknown, the cat # and lot # for the explanted duraloc cup is unknown.The original dos is unknown.Activity level - yes.Doi: unknown.Dor: (b)(6) 2023.Affected side: unknown hip side.

Manufacturer Narrative

Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.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.

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 (mre), was not possible because the required lot code was not provided.Removed pe code implant disassociation: locking mechanism.

• Brand Name: UNK HIP ACETABULAR CUP DURALOC
• Type of Device: HIP ACETABULAR CUP
• 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: 16873456
• MDR Text Key: 314614924
• Report Number: 1818910-2023-09679
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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 Catalogue Number: UNK HIP ACETABULAR CUP DURALOC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: DLT TS CER HD 12/14 36MM +1.5.; UNK CEMENT (UNK MANUFACTURER & PRODUCT INFO).; UNK STRYKER LINER.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female