MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 2.5 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158122008
Medical Device Problem Codes	Difficult to Insert (1316); Device Damaged Prior to Receipt by User (1570); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that when installing the polyethylene, it was noticed that the fitting was damaged/bent upwards, which made it impossible to correctly place the polyethylene on the tibia.A new polyethylene was opened to proceed with the procedure.The procedure was successfully completed with no surgical delay.There was no patient consequence.
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: h6 medical device problem code.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: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.
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: 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 according to the information received, ¿the customer reports that when installing the polyethylene, he noticed that the fitting was damaged, making it impossible to install it correctly.¿ the sigma stab gvf ins 2.5 8mm (lot.158122008) returned to medtech orthopaedics for evaluation.The medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned tibial insert revealed slight deformation and witness marks on one of the posterior locking features and its surrounding area.Additionally, deformation and signs of damage were also found on one of the anterior locking tabs, which corresponds to the same side as the damaged posterior locking feature.The sigma surgical technique advises the surgeon to place the tibial insert into the tibial tray by angling the tibial insert posteriorly and sliding the posterior tabs into the posterior undercuts of the tibial tray.The observed condition of the returned sigma stab gvf ins 2.5 8mm suggest that the implant was not aligned properly during insertion attempts, as the posterior tab appear to not have been fully aligned with the posterior undercuts of the tibial tray during insertion attempts.This would also explain the damage found on the anterior locking tabs if the posterior tabs were not properly engaged with the undercut of the tray.However, a definitive root cause could not be determined with the information available.The mating tibial tray component was not returned and due to the post-manufacturing damage, 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.A manufacturing record evaluation was performed for the finished device [prod.Code: 158122008 / lot: d24093346] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was as the observed condition of the locking mechanisms of sigma stab gvf ins 2.5 8mm would 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 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 [158122008 / d24093346] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review a manufacturing record evaluation was performed for the finished device [158122008 / d24093346] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.H11 additional narrative: added: d10 corrected: h3.

• Brand Name: SIGMA STAB GVF INS 2.5 8MM
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21541030
• Report Number: 1818910-2025-03573
• Device Sequence Number: 15217545
• Product Code: JWH
• UDI-Device Identifier: 10603295064084
• UDI-Public: (01)10603295064084(17)290831(10)D24093346
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,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: 158122008
• Device Lot Number: D24093346
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 03/07/2025; 05/14/2025; 08/19/2025; 10/17/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/10/2025; 05/14/2025; 08/21/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SIGMA STAB GVF INS 2.5 8MM
• Patient Sex: Unknown