MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIG RPF INS SZ 4 12.5MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Catalog Number	951041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Pfc sigma from 2015 revised due to patella fracture due to fall and subsequent infection.Poly was removed and exchanged for a new one.Doi: (b)(6) 2015.Dor: (b)(6) 2025.Affected side: left knee.
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 narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
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: b5, d10 (concomitant).Corrected: d4 primary udi number.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
Additional information received: a.Can you please confirm the primary cause for the revision? was it infection or patella fracture? -it was both - fractured patella had become infected thus the poly exchange.Patella implant not changed at this time.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, "pfc sigma from 2015 revised due to patella fracture and subsequent infection".The product was not returned to depuy synthes; however photos were provided for review.The photo investigation revealed nothing indicative of a device nonconformance.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 pfc sig rpf ins sz 4 12.5mm would not have 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 depuy synthes 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 device history record (dhr) review or manufacturing records evaluation (mre) was not possible because lot code provided is not a valid finished goods lot#.

• Brand Name: PFC SIG RPF INS SZ 4 12.5MM
• Common Device Name: PFC SIGMA RP-F : 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 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24057061
• Report Number: 1818910-2026-00701
• Device Sequence Number: 9421153
• Product Code: NJL
• UDI-Device Identifier: 10603295230427
• UDI-Public: (01)10603295230427(10)BFI0M25
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• 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,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 Catalogue Number: 951041
• Device Lot Number: BFI0M25
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 03/18/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/20/2026; 03/20/2026
• 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: UNKNOWN KNEE PATELLA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown