MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PRSVN ALLPOLY TIB RMLL SZ4 7MM; EARLY INTERVENTION : KNEE ALL POLY TIBIA

Catalog Number 149811406

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 03/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision total knee replacement: patient underwent bilateral uni-compartmental knee replacement on (b)(6) 2003.At this time both the right medial and the left medial compartments were replaced.The patient has presented with a painful right knee, right knee x rays show possible osteolysis around the tibial compartment.A decision was made to revise the right uni-compartmental knee to a total knee.On opening the knee, the all poly tibia was found to be loose but there was also progression of disease in both the lateral joint and the patella femoral joint.Both femoral and tibial components were removed a stemmed and sleeved attune tibial implant was inserted along with a primary attune ps femur.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no additional related incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PRSVN ALLPOLY TIB RMLL SZ4 7MM
• Type of Device: EARLY INTERVENTION : KNEE ALL POLY TIBIA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9959172
• MDR Text Key: 187615558
• Report Number: 1818910-2020-10754
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 149811406
• Device Lot Number: XL2DW4001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRESERVATION UNI FEM CEM SZ3; PRESERVATION UNI FEM CEM SZ3
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR