MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TIBIAL INSERT

Catalog Number UNK ANKLE TIBIAL INSERT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Report was initially submitted on (b)(6) 2019 but the third acknowledgment was not received.Advised by fda on (b)(6) 2020 to resubmit medwatch.(b)(4).

Event Description

The literature article entitled ¿intraoperative and perioperative complications during revision arthroplasty for salvage of a failed total ankle arthroplasty¿, written by joan r.Williams et al, published in foot and ankle international, volume 36(2) 135-142, 2015; was reviewed.The purpose of the study within the article was to review a series of failed agility taa revised to another competitor¿s implant and identify the reasons for revision as well as perioperative complications.The article reports the associated perioperative complications that clinicians encounter when revising failed agility taa are not well documented.A retrospective chart and radiographic review of 35 consecutive failed agility taa revised to a competitor¿s implant in 34 patients was performed for this study.All cases were completed between june 2011 and march 2013, allowing for a minimum of six months follow-up.Inclusion criteria included patients who presented with pain and a failed agility taa that was revised.Five patients were excluded because they revised to another agility taa, one patient excluded due to revision to another implant and nine were excluded because their procedure only involved polymer exchanges and cyst debridement with retention of the primary taa implants.34 patients met the inclusion criteria for the study.One patient had bilateral revisions.13 patients had a revision procedure, either complete revision or polymer exchange, prior to the conversion to the competitor implant.15 patients had additional procedures performed on the operative ankle prior to revision, which included realignment osteotomies, gutter debridement, and antibiotic cement spacer placement for infection.The initial agility taa was retained for an average of 49.6 months (7.2-113.0 months) prior to any revision surgery.Indications for revisions primarily involved mechanical loosening of the prosthesis, talar subsidence and osteolysis.All patients had symptoms of ankle joint pain and some had additional complaints of instability on clinical presentation.There was also one patient who suffered a dislocation of the ankle prosthesis and three who experienced a periprosthetic fracture.

• Brand Name: UNKNOWN ANKLE TIBIAL INSERT
• Type of Device: UNKNOWN ANKLE TIBIAL INSERT
• 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: 9903733
• MDR Text Key: 190673164
• Report Number: 1818910-2020-09736
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ANKLE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 03/31/2020
• 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