MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN TIBIAL STEM TRIALS; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-6403
Medical Device Problem Codes	Fracture (1260); Device-Device Incompatibility (2919); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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.
Event or Problem Description
It was reported that an x-ray image showed a metal component of the reaming device had come loose and remained in the femur.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device was not returned to depuy synthes for evaluation, however x-rays were provided for review.Review of the provided x-rays revealed unknown metal component remained in the femur.The potential cause is traced to user.The report allegation can be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Removed the reported date of implant in d6a.
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.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.A.What was the affected side? left, or right? -right b.Was the revision surgery performed? -no e.Was there any surgical delay? if yes, please provide the duration.-no f.Was there any patient harm relevant to this event? if yes, please provide the details.-no.

• Brand Name: UNKNOWN TIBIAL STEM TRIALS
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15409914
• Report Number: 1818910-2022-17743
• Device Sequence Number: 5512655
• Product Code: JWH
• UDI-Device Identifier: 10603295216919
• UDI-Public: 10603295216919
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 09/13/2022

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 Expiration Date: 03/18/2021
• Device Model Number: 86-6403
• Device Catalogue Number: UNK TIBIAL STEM TRIALS
• Device Lot Number: D16031408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 11/28/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/08/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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