MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CNTR HIP 44X22.225 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1037-44-000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Unspecified Tissue Injury (4559)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date, the primary surgery was performed with the implants in question.The surgery was completed successfully without any surgical delay.The event date is unknown.The revision surgery is scheduled on may 29 to replace the cup and the head.The cup will be replaced to other company¿s product.The stem will not be removed.More details will be updated as they become available.No further information is available.

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.

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: a1, a3, b3, b5, d4 (lot, catalog, udi), d6b, g4 (pma/ 510(k)), h4, h6 health effect - clinical code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2a, d2b, d10 (concomitant), h6 health effect - impact code.

Event Description

Additional information received.On (b)(6) 2023, the revision surgery was performed from 9:15am.The surgeon removed the bipolar cup and the head with bone fragment punching machine.The loosening of the stem was not confirmed and it was preserved.The cup was replaced to zb's g7 and argument implant.The surgery was completed successfully with dual mobility.No further information is available.

• Brand Name: SELF CNTR HIP 44X22.225 GRY
• Type of Device: 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: 17002886
• MDR Text Key: 315939060
• Report Number: 1818910-2023-10956
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003571
• UDI-Public: 10603295003571
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2023

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
• Device Operator: Health Professional
• Device Model Number: 1037-44-000
• Device Catalogue Number: 103744000
• Device Lot Number: XK5C31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/29/2023; 06/27/2023
• Supplement Dates FDA Received: 06/08/2023; 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 9/10 COCR HEAD 22.225MM +0; UNK HIP ACETABULAR LINER; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female