MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK BROACH; UNKNOWN BROACH

Catalog Number UNK BROACH

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

Patient Problem Bone Fracture(s) (1870)

Event Date 11/01/2017

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 ¿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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Additional narrative: product complaint # (b)(4).Investigation summary the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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: UNK BROACH
• Type of Device: UNKNOWN BROACH
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9646590
• MDR Text Key: 186844557
• Report Number: 1818910-2020-03531
• Device Sequence Number: 1
• Product Code: HTQ
• 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: 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 BROACH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention