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

Catalog Number UNK BROACH

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

Patient Problem Bone Fracture(s) (1870)

Event Date 06/20/2017

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 ¿porous-coated metaphyseal sleeves for severe femoral and tibial bone loss in revision tka¿ by tyler s.Watters, md, et al.Published in the journal of arthroplasty 32 (2017) 3468-3473, 20 june 2017, was reviewed.The purpose of the article was to evaluate the midterm results of stepped, porous-coated metaphyseal sleeves in a large series of revision tka operative procedures with severe bone loss.Products used: stepped, porous-coated, titanium metaphyseal sleeves (depuy); mobile-bearing revision tibial component, pfc sigma revision mbt (depuy); the femoral prostheses used included three hinged knees, 33 lcs varus valgus constraint knees, 65 pfc sigma total condylar 3 knees, and 15 pfc sigma posterior stabilized knees (depuy).Patients who had undergone revision tka (tibial and/or femoral revision with a bone defect) between 2006-2014 were identified.104 knees (98 patients, 134 sleeves) with a mean follow-up duration of 5.3 years (minimum 2 years) were included in the study.Results: statistically significant improvements were noted in knee range of motion.Only one tibial sleeve demonstrated radiographic evidence of failed osteointegration with a progressive radiolucency involving the baseplate and sleeve that ultimately led to subsidence and stem fracture.Interestingly, this patient is not symptomatic and has not yet required an additional revision procedure.There were three intraoperative fractures associated with sleeve preparation and/or insertion, all of which went on to heal.One patient sustained a nondisplaced metaphyseal femoral fracture during final component implantation and was treated with a single cerclage cable.Two patients sustained displaced, longitudinal tibial shaft fractures with sleeve preparation, one of which was treated with cerclage cables as discussed above and the other with plating.19 knees required reoperation, most commonly for recurrent infection, patellar crepitus, wound issues, and instability, respectively.Of the six recurrent infections, four patients were successfully treated with irrigation and debridement, polyethylene liner exchange with component retention, and appropriate antibiotic treatment.Two sleeves in two separate patients required removal as part of the resection for recurrent infection.One patient with a tibial sleeve required reoperation for aseptic loosening of his femoral component (no sleeve used) at 34 months; however, the tibial sleeve was stable and did not require revision.Overall, metaphyseal sleeve survivorship in this series was 98.5% for all-cause revision or removal with no cases of revision for aseptic loosening of any sleeve at a mean follow-up of 5.3 years.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthesof 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, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK BROACH
• Type of Device: UNK KNEE INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9622227
• MDR Text Key: 186000770
• Report Number: 1818910-2020-02650
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention