MAUDE Adverse Event Report: DePuy Ireland - 9616671 P.F.C. SIGMA RPF; PFC Sigma RP-F : Knee Femoral

Catalog Number	950014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2010, the patient underwent a tka with the product in question.The surgery was completed successfully without any delay.After the surgery on (b)(6) 2026, the hospital ordered replacement for a debridement and insert replacement following an infection.Upon checking with the logistics department, it was found that there was virtually no stock of rpf inserts remaining; as replacement with a new unit was not possible, the surgeon decided to thoroughly clean and reuse the existing insert.The surgery was completed successfully without any delay.Affected side: left.
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.H11.Additional manufacturer narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.

• Brand Name: P.F.C. SIGMA RPF
• Common Device Name: PFC Sigma RP-F : Knee Femoral
• Manufacturer (Section D): DePuy Ireland - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50945009
• Report Number: 1818910-2026-16852
• Device Sequence Number: 9552026
• Product Code: NJL
• UDI-Device Identifier: 10603295224020
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 950014
• Device Lot Number: EL1BN4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown