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

Catalog Number UNK KNEE FEMORAL SLEEVE

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

Patient Problems Wound Dehiscence (1154); Pulmonary Embolism (1498); Fall (1848); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Post Operative Wound Infection (2446)

Event Date 06/03/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: quinn j, jones p, randle r.A reliable surgical approach to revision total knee arthroplasty.Clin orthop surg.2022 jun;14(2):213-219.Doi: 10.4055/cios20207.Epub 2021 jun 3.Pmid: 35685980; pmcid: pmc9152900.Objective and methods: the purpose of this article is to report on the surgical procedure and 90-day complication rates for 202 pfc revision knees implanted between 2004 and 2015.The authors indicated that an unknown number of augments, sleeves, and stems were implanted along with the femoral component, tibial tray and tibial insert.There is insufficient information to determine if the natural patellas were resurfaced.The manufacturers of the products explanted during the revision as well as the cement utilized with the pfc sigma revision knees are unknown.This complaint will capture the information regarding the known 25 postoperative complications associated with the pfc sigma revision knee.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: tc3 femoral component, femoral augment, femoral adaptor, femoral bolt, femoral metaphyseal sleeve, and universal femoral stem; mbt tibial tray and tibial metaphyseal sleeve; pfc tibial insert; universal tibial stem.Adverse event(s) and provided interventions associated with depuy devices: 6 deep infections requiring revision of unknown products 9 reports stiffness and reduced rom treated with mua 1 hemarthrosis secondary to postoperative warfarin administration: conservative management unspecified 1 pe treated conservatively by pulmonologist 6 reports superficial surgical site infections: 1 treated with iv antibiotics, 5 treated with oral antibiotics.1 wound dehiscence secondary to fall from the hospital bed repaired surgically 1 report post operative pain requiring re-hospitalization.Treatment unspecified.

Manufacturer Narrative

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

• Brand Name: UNKNOWN KNEE FEMORAL SLEEVE
• Type of Device: KNEE FEMORAL SLEEVE
• 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: 15377466
• MDR Text Key: 299449637
• Report Number: 1818910-2022-17362
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL SLEEVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• 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