MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 3 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158123010
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent an unknown procedure on (b)(6) 2024.When impacted by the surgeon, the insert would not seat properly on the tibial tray implant.Another implant was opened and impacted on the tibial tray and seated normally without any issue.There was no patient consequence.There was no surgical delay.
Additional Manufacturer Narrative
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.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: when impacted by the surgeon, the insert would not seat properly on the tibial tray implant.Another implant was opened and impacted on the tibial tray and seated normally without any issue.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed that one of the locking tabs of the sigma stab gvf ins 3 10mm was found partially delaminated.Additionally small deformations can be found on the surface of the device most likely caused by the implantation attempts.The observed damage can be consistent with a component failure caused by excessive forces applied over material, like assembling the device in an off-axis position during surgical process.It is worth mentioning to remove loose fragments or particulates from the permanent tibial tray prior to implantation as per sigma primary knee system surgical technique.Properly handling and attention to the approved use of the device diminishes the risk of failure.A manufacturing record evaluation was performed for the finished device [158123010 / d24031598], and no non-conformances / manufacturing irregularities were identified.A dimensional inspection was not performed since it was not applicable to the complaint condition.The mating tibial tray component was not returned; therefore, a functional test was not able to be performed.However, due to the visual damage observed, the difficulty/inability to assemble mating devices can be confirmed.The overall complaint was confirmed as the observed condition of the sigma stab gvf ins 3 10mm 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 [158123010 / d24031598], and no non-conformances / manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device [158123010 / d24031598], and no non-conformances / manufacturing irregularities were identified.

• Brand Name: SIGMA STAB GVF INS 3 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20913697
• Report Number: 1818910-2024-25273
• Device Sequence Number: 8454056
• Product Code: JWH
• UDI-Device Identifier: 10603295064251
• UDI-Public: (01)10603295064251(17)20290131(10)D24031598
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033272
• 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: 158123010
• Device Lot Number: D24031598
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 02/14/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/08/2025; 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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