MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIGMA PLI XLK INS 5 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158105112
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Synovitis (2094); Swelling/ Edema (4577)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2008, the patient had a right total knee arthroplasty and tibial bone graft to address end-stage osteoarthritis.Depuy components were implanted during this procedure.On (b)(6) 2018, the patient had a revision right total knee replacement tibial and femoral component to address failed right total knee replacement secondary to wear and synovitis.The indications for surgery included episodes of recurrent scar formation, which required early manipulation and excision.A repeat arthroscopic excision for scar tissue and then underside of the quad tendon and now with recurrent stiffness and swelling.Radiographs were reported to show a radiolucent line around the femoral component.During the procedure, the surgeon observed the polyethylene had both front side and backside wear.The sigma pfc knee had a relatively high degree of posterior slope on the tibial side and the femoral implant did not have gross motion, but was relatively easy to remove after breaking up the interfaces with minimal bone ingrowth into the ingrowth surfaces on the backside of the implant.It was noted that the backside of the implants have small areas of spot welding, but the remainder did not have bone ingrowth.The tibial tray was noted to be well fixed, but was still removed.Patella remained in-situ.Competitor components were implanted during this procedure, including competitor cement.
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 narrative: e3 initial reporter occupation: lawyer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received,¿ on (b)(6) 2008, the patient had a right total knee arthroplasty and tibial bone graft to address end-stage osteoarthritis.Depuy components were implanted during this procedure.On (b)(6) 2018, the patient had a revision right total knee replacement tibial and femoral component to address failed right total knee replacement secondary to wear and synovitis.The indications for surgery included episodes of recurrent scar formation, which required early manipulation and excision.A repeat arthroscopic excision for scar tissue and then underside of the quad tendon and now with recurrent stiffness and swelling.Radiographs were reported to show a radiolucent line around the femoral component.During the procedure, the surgeon observed the polyethylene had both front side and backside wear.The sigma pfc knee had a relatively high degree of posterior slope on the tibial side and the femoral implant did not have gross motion, but was relatively easy to remove after breaking up the interfaces with minimal bone ingrowth into the ingrowth surfaces on the backside of the implant.It was noted that the backside of the implants have small areas of spot welding, but the remainder did not have bone ingrowth.The tibial tray was noted to be well fixed, but was still removed.Patella remained in-situ.Competitor components were implanted during this procedure, including competitor cement.Doi: (b)(6) 2008, dor: (b)(6) 2018 right knee¿.Product description: - sigma pli xlk ins 5 12.5mm product code: - 158105112 lot no: - 2650636 quantity of manufactured: - (b)(4) date of manufacturing: - 16-jun-2008 expiry date: - 30-june-2013 ifu reference: - 090200252.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.Device history lot product description: - sigma pli xlk ins 5 12.5mm product code: - 158105112 lot no: - 2650636 quantity of manufactured: (b)(4) date of manufacturing: - 16-jun-2008 expiry date: - 30-june-2013 ifu reference: - 090200252.Device history review a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: added: d10 corrected: d4 (expiration date, udi) and h4.

• Brand Name: SIGMA PLI XLK INS 5 12.5MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22123478
• Report Number: 1818910-2025-08731
• Device Sequence Number: 8678516
• Product Code: JWH
• UDI-Device Identifier: 10603295062806
• UDI-Public: (01)10603295062806(17)130630(10)2650636
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• 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: 06/30/2013
• Device Catalogue Number: 158105112
• Device Lot Number: 2650636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2008
• 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 POR FEM RT SZ 6; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG MOD TIB TRAY CEM COCR 5; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male