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

Catalog Number UNK ANKLE TIBIAL TRAY

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 01/01/2015

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 bone augmentation for revision total ankle arthroplasty with large bone defects.A technical note on 10 cases¿, by monika horisberger, et al, published in acta orthopaedica in 2015; was reviewed.The purpose of the article was to show how to perform revision taa in patients with substantial bone loss.The procedures described in the article were performed as a one stage or two stage revision.Two of the ten cases noted in the article were taa that were revised from an agility prosthesis (depuy).The indications for revision for all cases was aseptic loosening of the taa associated with extensive bone loss at the tibia, the talus, or both.In all cases preoperative diagnosis was posttraumatic osteoarthritis (oa).There were no intraoperative or postoperative complications.The two cases with agility prosthesis are noted below: at final follow-up, the tibial and talar components were radiographically stable.Patient 8: eight years until revision, one stage revision with bone augmentation of the tibia: 2x biocortical.

Manufacturer Narrative

Product complaint # (b)(4).Investigation 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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN ANKLE TIBIAL TRAY
• Type of Device: UNKNOWN ANKLE TIBIAL TRAY
• 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 46581-0988 ; 6107428552
• MDR Report Key: 9428371
• MDR Text Key: 185214502
• Report Number: 1818910-2019-121626
• 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: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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 TRAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/09/2020
• 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