MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 45X28 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number	103545000
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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 on (b)(6) 2025, there was a defective cup in failure of placement (imd).During an intermediate right hip prosthesis, the definitive acetabular implant does not clip correctly; the surgeon requests another implant.No significant slowdown on the duration of surgery, less than 5 minutes.
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 that 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 recon described in this report.H11 additional narrative: added: d9 if information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
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.H11 additional narrative: added: d4 (expiry date), h4.Corrected: d4 (primary udi number).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: defective cup in failure of placement (imd).During an intermediate hip prosthesis, the definitive acetabular implant does not clip correctly; the surgeon requests another implant.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance that would contribute to the reported complaint allegation.The evaluation of the returned device, as well as previous analysis performed of related complaints (b)(4), found that the observed slight toggle while the collar and liner are locked inside the cup is acceptable by design and would not contribute to premature failure of the components.Although there was slight movement with thumb pressure between the mating components, the components locked together correctly, and performed as design intended.Therefore, the alleged "mating parts do not fit together", is not confirmed and there is no manufacturing or design related product issues found of the mating components in the condition they were received.A manufacturing record evaluation was performed for the finished device product code: 103545000 lot number: d25061013, and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed as the observed condition of the self cent hip 45x28 gry would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device product code: 103545000 lot number: d25061013, and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product code: 103545000 lot number: d25061013, and no non-conformances or manufacturing irregularities were identified.Corrected: h3.

• Brand Name: SELF CENT HIP 45X28 GRY
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic drive; warsaw, IN 46582 ; 9083863534
• MDR Report Key: 23300708
• Report Number: 1818910-2025-17598
• Device Sequence Number: 10027831
• Product Code: KWY
• UDI-Device Identifier: 10603295003359
• UDI-Public: (01)10603295003359(17)300531(10)D25061013
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K812672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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

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 Catalogue Number: 103545000
• Device Lot Number: D25061013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 11/11/2025; 02/03/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/23/2025; 11/12/2025; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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
• Patient Sex: Unknown