MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PLI XLK INS 2.5 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-02-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686)
Date of Event	03/14/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Clinical adverse event received for loosening of the femoral component, possible deep infection: ulcer on knee as a result of cupping of her knee and this is draining; loosening of the femur on x-ray event is serious and is considered moderate.Event is probably related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2020.Date of event (onset): (b)(6) 2022.(right knee).Treatment: none - revision surgery pending.
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.Added: b5, h6 health effect - clinical code.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
Medical record received.On (b)(6) 2011, the patient had bilateral cemented total knee arthroplasties.Depuy components were implanted during this procedure.On (b)(6) 2022, the patient had a revision right total knee, all components to address septic loosening of the femoral component, draining sinus anteromedial tibia, and subcutaneous abscess medial aspect of the knee.The indications for surgery included increasing pain, redness and drainage.During the surgery, the surgeon reported finding chronic infection along with subcutaneous abscess over the medial aspect of the knee.While removing the patella, it was noted that the patella was ¿quite lytic¿.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.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.

• Brand Name: SIGMA PLI XLK INS 2.5 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14017506
• Report Number: 1818910-2022-06221
• Device Sequence Number: 20408419
• Product Code: JWH
• UDI-Device Identifier: 10603295062431
• UDI-Public: 10603295062431
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2022

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 Model Number: 1581-02-110
• Device Catalogue Number: 158102110
• Device Lot Number: 3303690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 03/29/2022; 05/06/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 04/12/2022; 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2011
• 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 C/R NPOR FE RT SZ2.5.; PFC*SIGMA/OV/DOME PAT 3PEG,38.; SIGMA PLI XLK INS 2.5 10MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 111 KG