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

Catalog Number UNK KNEE FEMORAL ADAPTOR

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 ¿management of bone defects in revision total knee arthroplasty with use of a stepped, porous-coated metaphyseal sleeve¿ by marc r.Angerame, md, et al.Published in the journal of bone and joint surgery, 2019, 9 (2): e14(1-14) on 24 april 2019, was reviewed.Products used: pfc sigma (depuy) the article reports that metaphyseal sleeve fixation in revision total knee arthroplasties with large femoral or tibial bone defects provides reliable stability of the construct while decreasing shear and torsional stresses at the cement-bone interface by sharing load with the metaphysis through biologic fixation.The authors describe the indications and contraindications for the use of metaphyseal fixation in revision tka prior to detailing the surgical technique.It is also stated that while the technique described is for the pfc sigma implant system, technique variations exist with sleeve systems from different manufacturers, although the principles described apply to most of the sleeve systems.Results: aseptic loosening is one of the most common failure modes of revision tka.The authors¿ center performed a review of metaphyseal sleeves used for severe femoral and tibial bone loss in revision tka.116 revision tka with the use of 152 metaphyseal sleeves (111 tibial and 41 femoral) were evaluated.16.4% required reoperation, most commonly for infection.Only one sleeve demonstrated failed osseointegration radiographically but did not require revision.There were three intraoperative fractures while broaching.Survivorship at 5.3 years based on all-cause sleeve revision was 97.8%.Longer follow-up is needed to determine the long-term durability of this methodology.Due to insufficient information, it cannot be determined that depuy implants were used in the initial operation.

• Brand Name: UNKNOWN KNEE FEMORAL ADAPTOR
• Type of Device: UNKNOWN KNEE FEMORAL ADAPTOR
• 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 ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9646515
• MDR Text Key: 185429921
• Report Number: 1818910-2020-03515
• Device Sequence Number: 1
• Product Code: HWT
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL ADAPTOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2020
• 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