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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2025
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional manufacturer narrative: d4: udi: as the reported lot number for the device involved in the event is invalid, the full udi is currently not available.
Event or Problem Description
It was reported that the locking mechanism of the bi-polar head implant did not work properly.Affected site - right hip.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, ¿it was reported that the locking mechanism of the bi-polar head implant did not work properly¿.After searching "d25044841","d250005614" and "d250005576" in etq, no record is displayed.After searching the product description in nr list exported from the etq system, all results have been reviewed, no case even similar to the issue described in this complaint is identified.After searching "d25044841","d250005614" and "d250005576" in sap by zqmr1023, an internal lock record of d25044841 is displayed not related with issue described in this complaint.Hereby drawing a conclusion that no non-conformance's were identified for this batch of products.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: after searching "d25044841","d250005614" and "d250005576" in etq, no record is displayed.After searching the product description in nr list exported from the etq system, all results have been reviewed, no case even similar to the issue described in this complaint is identified.After searching "d25044841","d250005614" and "d250005576" in sap by zqmr1023, an internal lock record of d25044841 is displayed not related with issue described in this complaint.Hereby drawing a conclusion that no non-conformance's were identified for this batch of products.H11 additional narrative: added: d6b, d10 (concomitant).

• 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): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23065029
• Report Number: 1818910-2025-15957
• Device Sequence Number: 21287676
• Product Code: KWY
• UDI-Device Identifier: 10603295003359
• UDI-Public: (01)10603295003359
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K812672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: D25044841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ARTICUL/EZE BALL 28 +8.5 BL.
• Patient Sex: Female