MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PRSVN ALLPOLY TIB LM/RL S4 7MM; EARLY INTERVENTION : KNEE ALL POLY TIBIA

Catalog Number 149812406

Device Problems Loss of or Failure to Bond (1068); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 04/28/2021

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

Patient underwent primary bilateral unicompartmental knee replacement for both the medial right and medial left compartments approximately 14 years ago.Patient had been doing well until approximately 1 year ago and his left knee has become progressively more painful, specifically on the medial side.On opening the knee the femoral component was found to be well fixed.The tibial component (all poly, preservation component) was not overtly loose but did not take much to remove it.Wear was evident.These components were removed and an attune with stemmed tibial component implanted.

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.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: PRSVN ALLPOLY TIB LM/RL S4 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: 11814079
• MDR Text Key: 250344996
• Report Number: 1818910-2021-10137
• 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,Followup
• Report Date: 04/28/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 149812406
• Device Lot Number: ZB3L14000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 04/28/2021; 07/15/2021
• Supplement Dates FDA Received: 05/18/2021; 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PALACOS CEMENT; PRESERVATION UNI FEM CEM SZ4; PRSVN ALLPOLY TIB LM/RL S4 7MM
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR