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 Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Injury (2348); Joint Disorder (2373); Osteolysis (2377); 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.

Event Description

On 23-sept-2019 literature article entitled: ¿midterm clinical and radiographic results of mobile-bearing revision total knee arthroplasty¿ by raymond h.Kim, md, j.Ryan martin, md, douglas a.Dennis, md, charlie c.Yang, md, jason m.Jennings, md, dpt, gwo-chin lee, md.Published by the journal of arthroplasty 32 (2017) was reviewed for mdr reportability.The study¿s objective was to evaluate the knee society scores and range of motion in patients undergoing revision tka using mobile bearing revision knee implants, assess the midterm radiographic results, and evaluate the survivorship, complications, revisions, and reoperations, including the incidence of bearing complications.Prosthetic systems used in this series of mobile-bearing revisions included the pfc sigma, lcs, and s-rom noiles depuy knee systems.A posterior-stabilized rotating platform bearing was used in 86 cases, a constrained condylar rotating bearing was selected in 191 cases, and a rotating hinge articulation was required in 3 cases.Modular femoral stem extensions were used in 205 knees, whereas modular tibial stem extensions were selected in 120 cases.Femoral metaphyseal sleeves were implanted in 9 knees and tibial metaphyseal sleeves were required in 71 cases.Lastly, femoral augments were used in 188 cases and tibial augments were selected in 26 cases.Please note, there is no information provided regarding original primary implants manufacturer.The study identified the following to be adverse outcomes, patient quantity is stated if provided: pain, bone loss and/or poor bone quality, ligamentous insufficiency or incompetence, polywear, osteolysis, 4 - abnormal radiographic evaluation indicating progressive radiolucent lines, 4 - prosthetic loosening of the femoral and tibial components, 11 - infection, 3 - adhesions, 2 - instability, 7 - symptomatic crepitus, 29 - revision / surgical intervention / irrigation and debridement.

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.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 : null.Device history batch : null.Device history review : null.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
• MDR Report Key: 9168058
• MDR Text Key: 172922674
• Report Number: 1818910-2019-108239
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention