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

Catalog Number UNK ANKLE TIBIAL TRAY

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Necrosis (1971); Pain (1994); No Code Available (3191)

Event Date 07/01/2018

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 ¿the effect of patient age and diagnosis on the 5-year outcomes of mobile-bearing total ankle replacement¿ written by s.E.Johnson-lynn, et al.Published in the elsevier journal the foot in july 2018; was reviewed.The purpose of the article was to report on the five-year results following mobile-bearing total ankle replacement, in relation to type of arthritis and age at the time of surgery.The foot and ankle score (faos) was validated in adults with arthritis.106 patients underwent total ankle replacement between march 2006 and december 2009, 76 of whom had completed five-year follow-up data and were included in the study.The mean age of patients was 63 years (range 32-80) and mean bmi was 28.5 (range 17.7-49.1) the underlying diagnosis leading to ankle replacement was primary osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.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: two patients experienced medial malleolar fractures; one required surgical intervention.One patient had persistent pain in the distribution of the superficial peroneal nerve.Three patients experienced superficial wound infections, which resolved with antibiotics.Three patients were revised at a mean of 4.8 years following surgery and a further patient is awaiting revision.The reasons for failure were varus instability in two patients, progressive loosening in one and talar subsidence on a background of talar avascular necrosis.

Manufacturer 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 TIBIAL TRAY
• Type of Device: ANKNLE 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
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9545595
• MDR Text Key: 184733315
• Report Number: 1818910-2020-00311
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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 TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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