MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ELITE MODULAR HD 28MM +0; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	9625-73-000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	05/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Primary total hip replacement in 1997, elite modular stem with duraloc cup and lipped liner.Liner wear resulting in revision surgery.No records available of the primary case.Right hip.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.
Event or Problem Description
Additional information received stated that the patient was revised due to dislocation.The surgeon commented that the soft tissue enveloped around the hip was not constrained due to the length of the time the previous implants have been in situ.
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 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.

• Brand Name: ELITE MODULAR HD 28MM +0
• Common Device Name: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10116506
• Report Number: 1818910-2020-13154
• Device Sequence Number: 19413148
• Product Code: JDI
• UDI-Device Identifier: 10603295243168
• UDI-Public: 10603295243168
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/23/2020

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: 9625-73-000
• Device Catalogue Number: 962573000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2020
• Supplement Date Received by Manufacturer: 06/14/2020; 06/14/2020; 07/02/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 06/24/2020; 06/26/2020; 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUR MAR 10D LINER 28IDX54OD; DURALOC DYNAMIC LOCK RING 54MM; DUR MAR 10D LINER 28IDX54OD; DURALOC DYNAMIC LOCK RING 54MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR