MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM RT SZ 4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number 96-0014

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Synovitis (2094); Osteolysis (2377); Joint Laxity (4526)

Event Date 12/12/2022

Event Type  Injury  

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.

Event Description

Clinical notification received for revision due to instability.Date of implant: (b)(6) 2006.Date of revision: (b)(6) 2022.(right knee).Treatment: revision; femoral component, tibial, insert, and patella were revised.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; the device associated with this report was not received for examination.Based on the visual analysis of the provided photographic evidence for, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.By the provided evidence, it cannot be determine a progressive decay of implant position in relation to initial implantation position.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.

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.H10 additional narrative: added: b1 (product problem), b5, b7, 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.Corrected: h6 medical device problem code.

Event Description

Medical records received.(b)(6) 2022: clinical visit to evaluate failed right total knee replacement.Radiographs indicate osteolysis impacting the tibia and femur.Plan to is perform right knee revision of all components, to address global instability, possible implant loosening, and osteolysis around component(s).(b)(6) 2022: the patient's right knee was revised, exchanging all components.The patient presented with global instability, polyethylene-mediated synovitis, osteolysis, and aseptic loosening of the femur and tibial tray components.The tibial insert and patella components both demonstrated significant wear, with the tibial insert also showing evidence of delamination, and fragmentation of the posterior lip of the insert.The tibial osteolytic lesion was significant, requiring cancellous allograft bone to fill.Implants replaced with depuy attune crs revision.

• Type of Device: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16088890
• MDR Text Key: 306549859
• Report Number: 1818910-2023-00217
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295232032
• UDI-Public: 10603295232032
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-0014
• Device Catalogue Number: 960014
• Device Lot Number: 106014BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2006
• 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: BONE CEMENT (UNK MANUFACTURER & PRODUCT INFO); MBT CEM KEEL TIB TRAY SZ4; PFC SIGMARP CV TB/IN S4 12.5; PFC*SIGMA/OV/DOME PAT 3PEG,41
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic
• Patient Race: White