MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CVTBIN S2.5 10.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Fever (1858); Unspecified Infection (1930); Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	12/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical notification received for revision due to infection.Date of implant: (b)(6) 2005.Date of revision: (b)(6) 2022.(right knee).Treatment: revision; insert was revised.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
Event or Problem Description
The patient underwent bilateral total knee replacements using depuy synthes implants including patella resurfacing on (b)(6) 2005.The cement manufacturer is unknown.On (b)(6) 2022, clinic visit notes state the patient fell 2 weeks prior on her knee.Over the next couple of days, the knee suddenly became swollen with increasing pain.The patient also has had low-grade fevers.Mild laxity and large effusions are noted during the physical exam.An aspiration was completed.Pending the results of the aspiration, an i&d with retention of components, stimulan, and iv antibiotics followed by oral antibiotics is planned.On (b)(6) 2022, the patient¿s aspiration is noted to be positive for gram-positive cocci and she undergoes an i&d.Gross pus and synovitis were noted.A suspected torn meniscus around the patella was excised.A slight wear pattern was noted on the patella but it was retained.The i&d was performed successfully.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PFC SIGMARP CVTBIN S2.5 10.0
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16145765
• Report Number: 1818910-2023-01053
• Device Sequence Number: 5753911
• Product Code: NJL
• UDI-Device Identifier: 10603295240679
• UDI-Public: 10603295240679
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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): 01/12/2023

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: 96-2021
• Device Catalogue Number: 962021
• Device Lot Number: 1862222
• 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: 12/30/2022
• Supplement Date Received by Manufacturer: 01/12/2023; 02/17/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 01/31/2023; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2005
• 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: MBT CEM KEEL TIB TRAY SZ2.5; PFC*SIGMA C/R NPOR FE RT SZ2.5; PFC*SIGMA/OV/DOME PAT 3PEG,35
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 77 KG