MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ3 RMLL; EARLY INTERVENTION : KNEE TIBIAL TRAY

Catalog Number	102452300
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inlay was not accepted by the partial tibia.There was a surgical delay of seventy (70) minutes.Changed to attune.There were no fragments generated.There were no patient consequences.
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.
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.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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that 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 : d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the inlay was not accept by the partial tibia.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the sigma hp uni tib tray sz3 rmll has signs of bone ingrowth adhered to the fixation surface.However, there are no signs of a device nonconformance that would contribute to the reported complaint.A functional test was unable to be performed due to the post-manufacturing damage of the mating device.However, due to the visual damage observed on the insert, the difficulty/inability to assemble mating devices can be confirmed.A manufacturing record evaluation was performed for the finished device [102452300 / m85z66] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed based on the visual examination of the insert condition.The sigma hp uni tib tray sz3 rmll would have not contribute 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 depuy synthes 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 [102452300 / m85z66] 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 [102452300 / m85z66] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified.Corrected: h3.

• Brand Name: SIGMA HP UNI TIB TRAY SZ3 RMLL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL TRAY
• 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: 22774135
• Report Number: 1818910-2025-14002
• Device Sequence Number: 21237817
• Product Code: NPJ
• UDI-Device Identifier: 10603295002390
• UDI-Public: (01)10603295002390(17)350228(10)M85Z66
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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,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: 102452300
• Device Lot Number: M85Z66
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 09/19/2025; 01/12/2026
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/17/2025; 09/29/2025; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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: SIGMA HP UNI INS SZ3 10MM RMLL.; SIGMA HP UNI INS SZ3 9MM RM/LL.
• Patient Sex: Female