MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ2 7MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number	102454207
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
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 during the surgery, surgeon could not lock the insert.Another device was used to complete the surgery.There were no adverse consequences to the patient.There was no delay to surgery.
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 hat 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 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: could not lock the insert.It was reported that during the surgery, could not lock the insert.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed slight deformations and marks on the surface that are consistent with the implantation attempts.A manufacturing record evaluation was performed for the finished device [102454207 / m5748u] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified.The sigma ''high performance partial knee' unicondylar surgical technique (dsus/jrc/1114/0582 rev.3), provide guidance to for a correct final implantation steps to be followed.Following these steps will successfully locking the insert into the base as intended, preventing the uni insert to be damaged.The observed damaged condition suggests an improper alignment when trying to introduce the uni insert through the tibial base locking edge.This would contribute to the difficulty/inability to mate the insert with the tibial component following multiple insertion attempts.A functional test was not performed since mating device was not returned for evaluation.However, due to the visual damage observed, the difficulty/inability to assemble mating devices can be confirmed.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the sigma hp uni ins sz2 7mm rm/ll 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 record evaluation was performed for the finished device [102454207 / m5748u] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified.Device history review: a manufacturing record evaluation was performed for the finished device [102454207 / m5748u] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified.H11 additional narrative: corrected: h3.

• Brand Name: SIGMA HP UNI INS SZ2 7MM RM/LL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21688475
• Report Number: 1818910-2025-04540
• Device Sequence Number: 9059312
• Product Code: NPJ
• UDI-Device Identifier: 10603295002789
• UDI-Public: (01)10603295002789(17)290228(10)M5748U
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070267
• 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

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: 102454207
• Device Lot Number: M5748U
• 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: 03/02/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 04/11/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/03/2025; 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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