MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TALAR

Catalog Number UNK ANKLE TALAR

Device Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Thrombosis (2100); Tissue Damage (2104); Impaired Healing (2378); No Code Available (3191)

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 purpose of the article was to provide a comprehensive review of various complications associated with taa, with a literature review and summation of the previously reported data.This was compared with survivorship and complication rates at the authors¿ unit.In this unit, 278 taa¿s performed by four foot and ankle surgeons over a period of six years (2008-2013) were reviewed.These included 184 mobility ankle systems, depuy; the remaining were competitor implants.Depuy products used: the mobility total ankle system which includes a cobalt-chrome tibial component, a uhmwpe bearing insert and a cobalt-chrome talar component.The adverse events that occurred are as follows: six had deep infection; 27 had medial malleolar fractures; four had lateral malleolar fractures; 20 had superficial infections; delayed wound healing in nine; medial gutter pain in 31 patient with the majority of these happening with mobility implants; 16 had aseptic loosening and osteolysis; seven ankles were revised due to edge-loading; one ankle experienced a polyethylene component fracture; and a venous thromboembolism occurred in two ankles.

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.H10 additional narrative: product complaint (b)(4).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.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 TALAR
• Type of Device: ANKLE TALAR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9545857
• MDR Text Key: 185367578
• Report Number: 1818910-2020-00330
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ANKLE TALAR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention