MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 43X28 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number	103543000
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the device was abnormally loose.There is clicking sound with ceramic head after implantation.Then the device was removed and another device was used to complete the surgery.The surgery was delayed for about thirty minutes.The patient is currently stable.
Additional Manufacturer Narrative
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.Additional narrative: h3, h6: a manufacturing record evaluation was performed for the finished device product description: self cent hip 43x28 gry cem product code: 103543000 lot: m1479w, and no non-conformance's nor manufacturing irregularities were identified.The product was not returned to depuy synthes, however photos were received for review.The photograph was reviewed, however it does not represent the reported complaint.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.A manufacturing record evaluation was performed for the finished device product description: self cent hip 43x28 gry cem product code: 103543000 lot: m1479w, and no non-conformance's nor manufacturing irregularities were identified.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the photograph provided is not representative of the reported complaint.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 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.
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: d9.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: loose issue.It was reported that during the surgery, the device was abnormally loose.There is clicking sound with ceramic head after implantation.Then the device was removed and another device was used to complete the surgery.The surgery was delayed for about 30 minutes.The patient is stable currently.The product was not returned to depuy synthes, however photos were provided for review.The photograph attached was reviewed, however does not represent the reported complaint.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.A manufacturing record evaluation was performed for the finished device product description: self cent hip 43x28 gry cem product code: 103543000 lot number: m1479w, and no non-conformances nor manufacturing irregularities were identified.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the photograph provided is not representative of the reported complaint.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 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 description: self cent hip 43x28 gry cem product code: 103543000 lot number: m1479w, and no non-conformances nor manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: self cent hip 43x28 gry cem product code: 103543000 lot number: m1479w, and no non-conformances nor manufacturing irregularities were identified.Added: d10 corrected: h6 health effect clinical code.

• Brand Name: SELF CENT HIP 43X28 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 dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24183541
• Report Number: 1818910-2026-01523
• Device Sequence Number: 18658273
• Product Code: KWY
• UDI-Device Identifier: 10603295003335
• UDI-Public: (01)10603295003335(17)270930(10)M1479W
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K812672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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,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: 103543000
• Device Lot Number: M1479W
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/03/2026; 02/19/2026; 06/16/2026; 06/17/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/09/2026; 03/03/2026; 06/17/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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 43X28 GRY.
• Patient Sex: Unknown