MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ6; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	960006
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Bone Notching (4890)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information received states that the left side is the affected side.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary attached implants have been revised.They were originally implanted in (b)(6) 2015.Loose femur.The product was not returned to j&j medtech orthopaedics; however, x-rays were provided for review.See attachment pfc revised (b)(6) grantham.The x-ray investigation revealed in the medial aspect a bone resorption of the medial condyle and a possible lateral displacement of the pfc*sigma c/r npor fem lt sz6.In the lateral aspect, the femoral component appears to be displaced to lateral.The evidence suggests that loosening and displacement have occurred; however, the absence of chronological data precludes confirmation of whether the implant was originally positioned in this manner.Although a specific root cause is not established for the loosening condition, there are many factors that could have contributed, including the improper fixation or separation of the bond observed between the bone and implant interface.However, 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 pfc*sigma c/r npor fem lt sz6 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 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: b5, d10 (concomitant).
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.
Event or Problem Description
It was reported that the knee implants have been revised due to loose femur.They were originally implanted on (b)(6) 2015.

• 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 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22574483
• Report Number: 1818910-2025-12679
• Device Sequence Number: 21191916
• Product Code: JWH
• UDI-Device Identifier: 10603295231981
• UDI-Public: (01)10603295231981(17)190501(10)532022
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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

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: 05/01/2019
• Device Catalogue Number: 960006
• Device Lot Number: 532022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2014
• 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: SIG MOD TIB TRAY CEM COCR 5; SIGMA PLI GVF INS 5 12.5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown