MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 COCR HEAD 28MM +6; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1521-90-060
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
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 in (b)(6) 2007.On (b)(6) 2021, the patient underwent the revision surgery due to the repeated dislocation.The surgeon commented that there were black deposits in the neck taper and head.Doi: (b)(6) 2007.Dor: (b)(6) 2021; unknown hip.
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.
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 : the device was implanted nearly 11 years prior a need for revision surgery.It is not suspected any error in device manufacture was the root cause for the problems reported.A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : update 29-jun-2021: the investigation was re-opened upon receipt of the device.Examination of the returned device confirmed the presence of corrosion.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: h3.

• Brand Name: 9/10 COCR HEAD 28MM +6
• 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: 11543614
• Report Number: 1818910-2021-05743
• Device Sequence Number: 17091676
• Product Code: JDI
• UDI-Device Identifier: 10603295276654
• UDI-Public: 10603295276654
• 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 Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/03/2021

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: 1521-90-060
• Device Catalogue Number: 152190060
• Device Lot Number: 2296379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/19/2021; 06/16/2021; 07/10/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/20/2021; 06/30/2021; 07/12/2021
• 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: 9/10 COCR HEAD 28MM +6; AML A PLUS 12.0 MM; CANCELLOUS BONE SCREW 6.5X15MM; CANCELLOUS BONE SCREW 6.5X20MM; CANCELLOUS BONE SCREW 6.5X25MM; DURALOC 1200 SERIES 50MM OD; ENDURON 10D 50OD X 28ID; 9/10 COCR HEAD 28MM +6; AML A PLUS 12.0 MM; CANCELLOUS BONE SCREW 6.5X15MM; CANCELLOUS BONE SCREW 6.5X20MM; CANCELLOUS BONE SCREW 6.5X25MM; DURALOC 1200 SERIES 50MM OD; ENDURON 10D 50OD X 28ID
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR