MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 57X28 BLU; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number	103557000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had unrecognized dislocation event.Upon closed reduction approximately 24 hours after dislocation, the bipolar head disassociated from the 28 mm femoral head.During the revision surgery, the bipolar head was found with plastic intact to the larger 57 mm head.The 28 mm femoral head was well fixed to the femoral stem.Surgical delay was unknown.Doi: (b)(6) 2025.Dor: (b)(6) 2025.Affected side: left hip.
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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
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: d10 concomitant, h4 corrected: d4 primary udi number.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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that the patient had unrecognized dislocation event.Upon closed reduction approximately 24 hours after dislocation , the bipolar head disassociated from the 28 mm femoral head.During the revision surgery, the bipolar head was found with plastic intact to the larger 57 mm head.The 28 mm femoral head was well fixed to the femoral stem.Surgical delay was unknown.The product was returned to j&j medtech orthopaedics for evaluation, additionally a product development investigation was performed for the complained device.Visual inspection of the returned device found some movement on the self cent hip 57x28 blu 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.A manufacturing record evaluation was performed for the finished device product description: self cent hip 57x28 blu product code: 103557000 lot number: d23053771 and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed as the observed condition of the self cent hip 57x28 blu 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 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 description: self cent hip 57x28 blu product code: 103557000 lot number: d23053771 and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: self cent hip 57x28 blu product code: 103557000 lot number: d23053771 and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: SELF CENT HIP 57X28 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 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21944342
• Report Number: 1818910-2025-06852
• Device Sequence Number: 12961812
• Product Code: KWY
• UDI-Device Identifier: 10603295003472
• UDI-Public: (01)10603295003472(10)D23053771
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K812672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 103557000
• Device Lot Number: D23053771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 12/06/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/16/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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 +1.5 GR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 73 KG