MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD GVF INS 5 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158115008
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377); Joint Laxity (4526)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
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 the patient underwent the revision of pfc due to lysis and instability.When the knee was opened, the polyethylene had some unnatural wear and signs of lysis.Cr femur, polyethylene and fb base were removed.Minimal bone loss on tibial side.Some bone lose on femoral side which bone graft was used to correct.Pt had minimal signs of infection so proceeded to implant attune revision.Good stability attained with stems and sleeves both sides.The procedure was successfully completed with no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - revision of pfc due to lysis and instability.Original surgeon was [removed].When the knee open the polyethylene had some unnatural wear and signs of lysis.Cr femur, polyethylene and fb base were removed.Minimal bone loss on tibial side.Some bone lose on femoral side which bone graph was used to correct.Pt had minimal signs of infection so proceeded to implant attune revision.Good stability attained with stems and sleeves both sides.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.(b)(4).Visual inspection revealed signs indicating that the device had been implanted for an extended period.In addition to the observed eccentric wear, one of the condylar surfaces appeared deformed, most likely due to abnormal weight loading on one side of the condyle.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the sigma crvd gvf ins 5 8mm 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 search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SIGMA CRVD GVF INS 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22398119
• Report Number: 1818910-2025-11302
• Device Sequence Number: 4799741
• Product Code: JWH
• UDI-Device Identifier: 10603295063575
• UDI-Public: (01)10603295063575(17)141221(10)D09120229
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2014
• Device Catalogue Number: 158115008
• Device Lot Number: D09120229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 09/12/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/13/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2020
• 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: PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG C/R POROCOAT FEM LT SZ 5; SIG MOD TIB TRAY CEM COCR 5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male