MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 55X28 BLU; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number	103555000
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intermediate hip prosthesis procedure, the definitive acetabular implant does not clip in correctly; there is persistent instability between (pe) and the metal back.After several assembly attempts (with and without the cocr head) on the table, the surgeon requested another implant.No clinical consequences.There was a 5 minutes of extension to the surgical procedure.
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 medwatch, a follow-up medwatch 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 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 reconstruction, or its employees caused or contributed to the potential event 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: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received states that the cup was not decontaminated as it did not come into contact with the patient or biological fluids.This was tested by the block nurse before implantation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: during an intermediate hip prosthesis procedure, the definitive acetabular implant does not clip in correctly; there is persistent instability between (pe) and the metal back.After several assembly attempts (with and without the cocr head) on the table, the surgeon requests another implant.No clinical consequences.There is no significant impact on the duration of surgery, with less than 5 minutes of extension to the surgical procedure.The product was returned to j&j medtech orthopaedics for evaluation.The complaint unit was forwarded to the product development team.Visual analysis of the self cent hip 55x28 blu revealed no significant damage or visual defects that could have contributed to the reported event.Following the in-person review of the items, the movement described in the complaint was reproducible and the decision was made to complete a dimensional inspection of the mating features of the components.The components had been assembled and disassembled multiple times since initial production through the customer use and subsequent internal company investigation.The dimensional inspection was completed with ct inspection equipment while the components were in the as-assembled, constrained condition.The dimensions measured on the cup and the bearing insert components measured within the print tolerances.Some of the locking ring dimensions measured larger than the print tolerances.It was concluded that those features were influenced by the condition of the poly collar, which may have become deformed through the process of implanting and removing the product in the shell more than in normal use.Based on the measurements, there is no manufacturing defect noted and 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 clipped together correctly, and performed as design intended.Therefore, the alleged "implant does not clip in correctly" is not confirmed and there is no manufacturing or design related product issues found of the mating components in the condition they were received.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 j&j medtech orthopaedics 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: 103555000 lot number: m7083p, and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: SELF CENT HIP 55X28 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22311407
• Report Number: 1818910-2025-10361
• Device Sequence Number: 8857337
• Product Code: KWY
• UDI-Device Identifier: 10603295003458
• UDI-Public: (01)10603295003458(17)290731(10)M7083P
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K812672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 103555000
• Device Lot Number: M7083P
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 07/23/2025; 10/30/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 06/25/2025; 07/24/2025; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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