• 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 TALAR

  • 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 TALAR Back to Search Results
Catalog Number UNK ANKLE TALAR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Not Applicable (3189); No Code Available (3191)
Event Date 01/01/2018
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 sagittal and coronal balance on patient-reported outcomes following mobile bearing total ankle replacement¿ written by sarah johnson-lynn et al. , published in the journal of foot and ankle surgery, in 2018; was reviewed. The purpose of the article was to determine the relative importance of the pre- and post-tar coronal and sagittal balance on proms in the united kingdom population, and to determine whether the cause of ankle arthritis is associated with the degree of pre- or postoperative deformity. 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 study was based on 101 tar¿s in 99 patients who participated in the minimum two-year follow-up. The study used radiographic assessment and statistical analysis. There were different groups for analysis¿an osteoarthritis group, a posttraumatic arthritis group and a rheumatoid arthritis group. They took different measurements pre and postoperatively which were the anterior distal tibial angle (adta); medial distal tibial angle (mtda); and the tibiotalar ratio (ttr). There were three revision surgeries during the follow-up period, although no further information was given regarding why. There were no significant differences between the groups. In conclusion, there were more patients with varus malalignment in the ptoa and oa groups and more valgus malalignment in the ra group, there was no significant difference in preoperative coronal and sagittal plane deformity between patients with ra, ptoa and oa. Moreover, there was no statistically significant correlation between preoperative deformity and postoperative function, as measured by the aofas hindfoot-ankle score. Faos. Or sf-36 scores. Furthermore, postoperative sagittal plane alignment did not correlate significantly with postoperative function, as measured by the aofas hindfoot ankle score, faos, or sf-36 scores. Finally, coronal plane alignment, as measured by the mdta, was significantly correlated with the postoperative aofas hindfoot-ankle score and the function subscale of the faos score. The faos still reported stiffness and pain in all groups. It was also noted that due to the short follow-up period, it cannot be determined if the influence of alignment impacts failure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN ANKLE TALAR
Type of DeviceUNKNOWN ANKLE TALAR
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 dr
warsaw, IN 46581-0988
6103142063
MDR Report Key9574374
MDR Text Key185737912
Report Number1818910-2020-01399
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 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK ANKLE TALAR
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 Received02/13/2020
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 Treatment Data
Date Received: 01/10/2020 Patient Sequence Number: 1
-
-