MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1014-70-000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
It was reported that the patient's right hip was revised due to chronic dislocations.The patient told to surgeon, that her current dislocated hip was her third dislocation.Patient's depuy hip had been previously revised elsewhere.During that procedure, it appears that, primary duraloc liner was replaced by a duraloc constrained liner, based upon the patient's current components.During this particular dislocation.The outer locking ring of the constrained liner had become separated from the liner and the femoral head had become dislocated from the liner.During this particular revision procedure, the duraloc cup, liner and locking ring were removed and replaced by a larger stryker acetabular cup.The depuy 32mm large taper metal femoral head was replaced by a depuy 36mm large taper metal femoral head.The patient's aml did not need to be replaced.There was no loosening.Surgical delay was unknown.Doi: unknown, dor: (b)(6) 2022, affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Common Device Name: LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS
• 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 46581-0988 ; 3035526892
• MDR Report Key: 15391653
• Report Number: 1818910-2022-17502
• Device Sequence Number: 17407409
• Product Code: JDI
• UDI-Device Identifier: 10603295001270
• UDI-Public: 10603295001270
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K880269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2022

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: 1014-70-000
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Device Lot Number: 8000382
• 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: 08/20/2022
• Supplement Date Received by Manufacturer: 10/18/2022; 12/27/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/26/2022; 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 14/16 LARGE TAPER METAL FEMORAL HEAD, 32MM +11; D 32MM T, DURALOC CONSTRAINED LINER LOCKING RING; D 32MM T, DURALOC CONSTRAINED LINER LOCKING RING; DURALOC ACETABULAR CUP, 52MM; DURALOC ACETABULAR CUP, 52MM; DURALOC CONST LINER 52X32; UNKNOWN HIP ACETABULAR LINERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female