MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 52X22.225 BLU; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number	1037-52-000
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); Unspecified Musculoskeletal problem (4535)
Date of Event	04/05/2022
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
It was reported that on (b)(6) 2004, the patient underwent a bha surgery for necrosis of femoral head.After surgery, on (b)(6) 2022, dislocation occurred, and a revision surgery was performed on the same day.The skirt part of the inner head hit the cup, and the cup was observed to be worn.In the revision surgery, the cup was removed and exchanged with a cup of the same size, and the inner head was re-inserted.The revision surgery was completed successfully with no surgical delay.The surgeon commented that the dislocation was considered to occur due to wear of the cup.No further information is available.Doi: (b)(6) 2004; dor: (b)(6) 2022; unknown hip.
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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SELF CENT HIP 52X22.225 BLU
• Common Device Name: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14249879
• Report Number: 1818910-2022-07835
• Device Sequence Number: 4397911
• Product Code: KWA
• UDI-Device Identifier: 10603295003656
• UDI-Public: 10603295003656
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 1037-52-000
• Device Catalogue Number: 103752000
• Device Lot Number: XS4FD1001
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2003
• 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: SELF CENT HIP 52X22.225 BLU; UNK HIP FEMORAL HEAD; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male