• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TIBIAL TRAY ANKNLE TIBIAL TRAY Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN ANKLE TIBIAL TRAY
Type of DeviceANKNLE 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 Key9545595
MDR Text Key184733315
Report Number1818910-2020-00311
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
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 Received01/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK ANKLE TIBIAL TRAY
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2020
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 Treatment Data
Date Received: 01/03/2020 Patient Sequence Number: 1
-
-