MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ELITE MODULAR HD 26MM +0; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	9625-70-000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
The primary surgery was performed on (b)(6) 2001.It was reported that the revision surgery was scheduled on (b)(6) 2020 due to several times dislocation.No further information is available.
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 - there is no evidence that initial manufacturing or material error would be a contributing factor after this length of time in-situ.A manufacturing records evaluation (mre) would not performed even if the lot information was known.

• Brand Name: ELITE MODULAR HD 26MM +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: 11020079
• Report Number: 1818910-2020-27057
• Device Sequence Number: 19819473
• Product Code: JDI
• UDI-Device Identifier: 10603295318101
• UDI-Public: 10603295318101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9625-70-000
• Device Catalogue Number: 962570000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/14/2021
• 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: CANCELLOUS BONE SCREW 6.5X15MM.; CANCELLOUS BONE SCREW 6.5X20MM.; CANCELLOUS BONE SCREW 6.5X20MM.; CEMENT RESTRICTOR SIZE 3.; DURALOC 1200 SERIES 50MM OD.; ELITE PLUS SZ 2 FLANGED.; ENDURON LINER NEUT 26ID X 50OD.; STREAMLINE SZ 12.0 PK/10.; UNK HIP LOCKING RING.