MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 COCR HEAD 22.225MM -3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1521-90-051
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	09/01/2020
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 on (b)(6) 1999 via tha for the patient's left hip joint at another hospital ((b)(6) hospital).The patient's postoperative progress was good over the long term.However, from (b)(6) 2020, the repetitive dislocation occurred.And with it, the patient had a pain.The revision surgery was performed on (b)(6) 2020 at (b)(6) hospital due to the repetitive dislocation.In the revision surgery, the surgeon remained the stem and the cup, he replaced the liner and the head (also replaced the locking ring along with it.) during the surgery, the surgeon found discoloration and wear on the liner.About the head, it was found that according to the sales records, the implanted one was +3mm, but when the sales rep checked the explanted actual item, it was actually -3mm.Both of interoperative trailing and after implanted stability of the hip joint was well.The surgery was completed without any surgical delay.The surgeon commented that the postoperative opinion was good from checking by x-ray, and the patient will be under follow-up.Before, the dates were unknown, the patient had the primary surgery for the right hip joint via tha and also had the primary surgery for the knee joint via tka at (b)(6) hospital.She has rheumatism.No further information is available.
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.H10 additional narrative: added: h6 (clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (medical device problem code), h8.H6 medical device problem code: code for off-label use is being retracted.
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 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 device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: 9/10 COCR HEAD 22.225MM -3
• 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: 11140077
• Report Number: 1818910-2021-00683
• Device Sequence Number: 3950164
• Product Code: JDI
• UDI-Device Identifier: 10603295276562
• UDI-Public: 10603295276562
• 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: 1999
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 12/23/2020

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: 1521-90-051
• Device Catalogue Number: 152190051
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 12/23/2020; 03/18/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 01/22/2021; 03/18/2021
• 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: AML A PLUS 10.0 MM; CB DURALOC 10DEG LINER 48MM; DURALOC 300 SERIES 48MM OD; AML A PLUS 10.0 MM; CB DURALOC 10DEG LINER 48MM; DURALOC 300 SERIES 48MM OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 58