MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL SLEEVE

Catalog Number UNK KNEE TIBIAL SLEEVE

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

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

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.(b)(4).

Event Description

The literature article entitled, "clinical and radiographic results of the total condylar iii and constrained condylar total knee arthroplasty" written by paul f.Lachiewicz, md and stephen p.Falatyn, md published by the journal of arthroplasty vol.11 no.8 1996 was reviewed.The article's purpose was to report upon clinical and radiographic results of a prospective consecutive series of tcp ii and non depuy prosthesis.Data was compiled from 36 patients with 46 primary and revision tkas performed between june 1984 and september 1992 with age ranges 44-91 years old.The article provides that revision tkas utilized tibial wedges, tibial and femoral stems, and femoral "extensions" when appropriate.Cement manufacturer is not identified and the original implants for revisions were not known.No patella resurfacing.The article does not identify which specific products are associated with the adverse events with the exception of a few adverse events identified with the non-depuy products.This complaint captures the adverse events without identification as none were specifically identified with depuythe article does not provide adequate information to determine accurate quantities.Depuy products utilized: tc3 primary and revision prosthesis including tibial wedges adverse events: pain with limited range of motion due to arthrofibrosis (intervention not specified), patellar crepitus with pain (intervention not specified), infection (treated by debridement and exchange of poly liner and iv antibiotics & chronic oral antibiotic for suppression), partial peroneal nerve palsy (self resolved by 3 weeks), limited range of motion (treated by manipulation under anesthesia).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN KNEE TIBIAL SLEEVE
• Type of Device: KNEE TIBIAL SLEEVE
• 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 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9420522
• MDR Text Key: 184854367
• Report Number: 1818910-2019-121123
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL SLEEVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention