MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICUL TR BALL GRVD 36 +5; FEMORAL TRIALS

Catalog Number	253152000
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Naturally Worn (2988); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 the head trials were worn, scratched and chipped.It did not happen in surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary it was reported that top layer of tray was cracked.T handle was cracked.All head trials were worn, scratched and chipped.It did not happen in surgery.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed deep scratches around the device's surface, making the product information illegible.Additionally, device exhibited signs of heavy usage.However, no signs of a stripped condition nor breakage could be identified over the device surface.Scratches observed were consistent with other tools and hard edges coming in contact with the device.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.A manufacturing records evaluation (mre) was not performed as no lot number was able to be retrieved for this device.If the lot/serial number becomes available, the record will be re-assessed.The overall complaint was confirmed as the observed condition of the articul tr ball grvd 36 +5 would have 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 records evaluation (mre) was not performed as no lot number was able to be retrieved for this device.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: ARTICUL TR BALL GRVD 36 +5
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20579002
• Report Number: 1818910-2024-22789
• Device Sequence Number: 18273015
• Product Code: HWT
• UDI-Device Identifier: 10603295129196
• UDI-Public: (01)10603295129196
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 10/31/2024

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: 253152000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown