MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIPOLAR TRL RETAINING CLIP 28; HIP INSTRUMENTS: FEMORAL HEAD TRIAL

Catalog Number	205516000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
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.
Event or Problem Description
It was reported that retaining clip no longer retains 28 head inside bipolar shell.There was no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that retaining clip no longer retains 28 head inside bipolar shell.Will be returned.No surgical delay.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the bipolar trl retaining clip 28 was chipped at the distal section near the holes.Additionally some scratches and slightly deformation were observed at the entire surface of the sample.The discrepancy of the device circumference was traced to design, as material extruded was changing in the field after autoclaving.A functional test could not be performed as the mating device was not returned.However, the retain issues can be confirmed due to device design issue.The observed chipped/scratched condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces, such as, heavy usage while handling the device and disassembling the device with not intended instruments.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the bipolar trl retaining clip 28 would have contributed to the complained issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the j&j medtech orthopaedics nonconformance (nc) quality system found a nc associated with this product/lot combination.Added: d9.Corrected: h3.

• Brand Name: BIPOLAR TRL RETAINING CLIP 28
• Common Device Name: HIP INSTRUMENTS: FEMORAL HEAD TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23348278
• Report Number: 1818910-2025-17894
• Device Sequence Number: 18527797
• Product Code: HWT
• UDI-Device Identifier: 10603295084501
• UDI-Public: (01)10603295084501(10)HW90342
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 205516000
• Device Lot Number: HW90342
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male