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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM ANKLE TIBIAL BASE SIZE 3 ANKLE PROSTHESIS

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ZIMMER BIOMET, INC. TM ANKLE TIBIAL BASE SIZE 3 ANKLE PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Malposition of Device (2616); Migration (4003)
Patient Problems Pain (1994); No Information (3190)
Event Date 10/13/2014
Event Type  Injury  
Manufacturer Narrative

(b)(4). Udi # n/a. Barbara h currier, paul j hecht, james a. Nunley ii, michael b mayor, john h currier, douglas w. Van citters (2018). Ankle arthroplasty: what retrievals can tell us. American orthopaedic foot & ankle society. Https://doi. Org/10. 1177/1071100718802589. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 06300, 0001822565 - 2018 - 06303. Not returned to manufacturer.

 
Event Description

It has been reported in the research article that, one patient had an ankle arthroplasty. Subsequently patient was revised approximately 0. 8 years post initial surgery due to malposition. Burnishing was noted on the retrieved poly. Attempts have been made and no further information has been provided.

 
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Brand NameTM ANKLE TIBIAL BASE SIZE 3
Type of DeviceANKLE PROSTHESIS
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 Key8054694
MDR Text Key126646391
Report Number0001822565-2018-06301
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE,STUDY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00450004300
Device LOT Number62510816
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/28/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 11/09/2018 Patient Sequence Number: 1
Treatment
UNKNOWN INSERT; UNKNOWN TALAR COMPONENT
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