MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM LT SZ 5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	940015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); 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.Additional narrative: d4: udi: as the catalog/model number was not provided, the (01) gtin is not available.H3, h6: photo investigation: the product was not returned to j&j medtech orthopaedics; however, photos were provided for review.The photo investigation revealed that a large portion of the fixation surface of the knee femoral sigma was covered with organic material and what appears to be bone integration.However, no indications of device nonconformance that could have contributed to the reported event were observed.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 not confirmed as the observed condition of the unk knee femoral sigma would have not contributed to the reported adverse event.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 records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.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.The photo investigation revealed that a large portion of the fixation surface of the knee femoral sigma was covered with organic material and what appears to be bone integration.However, no indications of device nonconformance that could have contributed to the reported event were observed 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 not confirmed as the observed condition of the unk knee femoral sigma would have not contributed to the reported adverse event.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H11 additional narrative: added: d4 (lot, expiration date), d10 and g4 corrected: d1, d2a, d2b, d4 (catalog, udi).

• Brand Name: SIG C/R POROCOAT FEM LT SZ 5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• 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: 22398167
• Report Number: 1818910-2025-11303
• Device Sequence Number: 15613079
• Product Code: MBH
• UDI-Device Identifier: 10603295223412
• UDI-Public: (01)10603295223412(17)190501(10)DT4J71
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062654
• 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

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 940015
• Device Lot Number: DT4J71
• 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
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 MOD TIB TRAY CEM COCR 5; SIGMA CRVD GVF INS 5 8MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male