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

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TALAR COMPONENT GREEN SIZE 5 RIGHT PROSTHESIS, ANKLE

  • 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
 

ZIMMER BIOMET, INC. TALAR COMPONENT GREEN SIZE 5 RIGHT PROSTHESIS, ANKLE Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device (1395); Noise, Audible (3273)
Patient Problem Swelling (2091)
Event Date 05/23/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi) #: n/a. Concomitant medical : item # 00450004500, tm ankle tibial base size 5, lot 00077003944; item # 00450005500, prolong tibial insert sz 5 +0, lot # 00062560621; item # 00493600703, locking one-third tubular plate 7 holes 94 mm length, lot # 00060864063. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 05154, 0001822565 - 2018 - 05156, 0001822565 - 2018 - 05157.
 
Event Description
It was reported that approximately three (3) years post implantation, the patient noted clicking/locking, with mild swelling and stiffness. X-ray has also indicated subsidence of the talar component. No medical intervention at this time. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. The following sections were update/corrected updated: reported event was confirmed by review of radiographs. X-ray review demonstrated the subsidence of the talar component. There is also slight increase in density of the talus adjacent to the component. The syndesmotic screw fracture that was previously reported could be a contributing factor to the subsidence. Hcp recommends a ct exam to exclude talar fracture as a cause of subsidence. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined with the information provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTALAR COMPONENT GREEN SIZE 5 RIGHT
Type of DevicePROSTHESIS, ANKLE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7903348
MDR Text Key121515233
Report Number0001822565-2018-05155
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK120906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00450002500
Device Lot Number62428993N
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 Received10/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2014
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: 09/24/2018 Patient Sequence Number: 1
-
-