MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA/OV DOME PAT 3 PEG,32; SIGMA KNEE PRIMARY : KNEE PATELLA

Catalog Number 960100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Synovitis (2094); Osteolysis (2377)

Event Date 11/12/2020

Event Type  Injury  

Event Description

Litigation complaint received ad 12 mar 2024 was reviewed by clinician.On (b)(6) 2014, the patient had a bilateral cemented total knee arthroplasty to address, bilateral knee pain and bilateral knee osteoarthritis end-stage.All components implanted were depuy products, including the cement and patella.On (b)(6) 2020, the patient had a right total knee arthroplasty, to address mechanical loosening of internal right knee prosthetic joint.The surgeon reported finding tibial tray loosening.The femoral component was well fixed, but there was significant osteolysis behind the femoral implant with large cavitary defect.Significant synovitis was also noted.Competitor products were implanted during this procedure.Doi: (b)(6) 2014 dor: (b)(6) 2020 right knee.

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - 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.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.

• Type of Device: SIGMA KNEE PRIMARY : KNEE PATELLA
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18993264
• MDR Text Key: 338817190
• Report Number: 1818910-2024-06968
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295232605
• UDI-Public: 10603295232605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 960100
• Device Lot Number: D14050423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MBT CEM KEEL TIB TRAY SZ1.5; PFC SIGMARP STB TB IN 1.5 10.0; SIGMA PS CEM FEM SZ1.5 R
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female