MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 INS 12.5MM, SZ3; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Catalog Number	960531
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/16/2025
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 j&j medtech, or its employees that the report constitutes an admission that the product, j&j medtech, 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: as the reported lot number for the device involved in the event is not valid, the full udi is currently not available.H3, h6: no device associated with this report was received for examination.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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
This report captures the infection that occurred after the 1st revision surgery.It was reported that on unknown date, the patient underwent the unknown initial surgery treating the left knee.It is unknown whether the implants used in the initial surgery were j&j¿s products or not.After the initial surgery, on (b)(6) 2020, the patient underwent the 1st revision surgery with pfc sigma products.The reason for the 1st revision surgery was infection.The 1st revision surgery was completed successfully with no surgical delay.After the 1st revision surgery, infection occurred again.The 2nd revision surgery will be performed.In the 2nd revision surgery, the insert will be removed and debridement will be done for initial treatment, after which a new insert will be inserted.No further information is available.This pc is related to (b)(4) which reports about the event regarding the 2nd revision surgery.

• Common Device Name: SIGMA REVISION IMPLANT : 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: 21994582
• Report Number: 1818910-2025-07512
• Device Sequence Number: 4618619
• Product Code: JWH
• UDI-Device Identifier: 10603295233138
• UDI-Public: (01)10603295233138
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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

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: 960531
• Device Lot Number: C7405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/09/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown