MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN FINGER IMPLANT

Catalog Number UNK FINGER

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).1st ip is to capture the hac cup.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device was received.Root cause undetermined.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.(b)(4).

Event Description

The literature article entitled "results with the roseland hac trapeziometacarpal prosthesis after more than 10 years¿, written by a.Semere et al; published in chirurgie de la main 34 (2015) 59-66; was reviewed.The purpose of the study was to evaluate long-term outcomes¿functional, clinical and radiographic results---with the roseland hydroxyapatite-coated prosthesis (depuy).The study was retrospective, non-controlled, single-center study involving multiple surgeons.There were 75 patients (101 thumbs) that underwent cmc joint replacements using the roseland hac prosthesis between 1996 and 2002 undergoing clinical and radiological review in 2013.24 patients were excluded, five refused to consent to participation, 14 were lost to follow-up and five had died by the time of review.In the end, 51 patients (64 thumbs) were included in the study.Mean follow-up was 12.5 years.Osteophytes were also observed.All patients were satisfied to very satisfied with the majority reporting no pain or only occasional pain.Radiographically, implant subsidence and periprosthetic osteolysis were frequently observed.No dislocation at the time of the review.Complications occurred in 16 of 64 cases, six which required explanation of the prosthesis and were excluded from the review of the long-term clinical results.In one case, a traumatic trapezium fracture needed revision one year postoperatively, because of pain and functional deficits.After one and nine years, two implants had loosened from their trapezial socket without subsidence or visible trapezium fracture, significantly altering the cup orientation.These cases were traumatic, probably linked to excessive distraction or moments at the thumb, leading to separation of the bone-implant interface.One case of trapezium metallosis at seven years postoperatively was confirmed by histopathology analysis.In one case, pain was persistent 12 years after surgery in a context of pancarpal osteoarthritis.This condition appeared after the thumb cmc arthroplasty, and the patient underwent multiple carpal procedures that were unsuccessful at changing the pain level.All these patients underwent trapeziectomy with interposition of a non-depuy synthetic implant.Five other trapezium fractures occurred between 10 and 16 years postoperatively, three of which were discovered by chance; all were immobilized until the pain decreased.In these cases, the trapezial implant sank beyond the bottom of the fractured trapezium in the stt, without changing its orientation.The cause was traumatic, probably linked to excessive acute or repeated axial compression.Two neuromas of the dorsal branch of the radial nerve were treated by excision.Three case of complex regional pain syndrome (crps) resolved with conservative treatment.Although the complication rate was high, these complications typically occurred early, were due to trauma or brought on by a technical error during the surgery; seldom was prosthesis removal needed.Trapezium fractures were always traumatic (fall from standing height), but poor preoperative radiological assessment of trapezium height, or an error when centering the trapezial implant during the surgery may have contributed to early trapezium fractures; similarly, late trapezium fractures could have been due to progressive implant subsidence.

• Brand Name: UNKNOWN FINGER IMPLANT
• Type of Device: FINGER IMPLANT
• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9452268
• MDR Text Key: 173000693
• Report Number: 1818910-2019-119901
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FINGER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• 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