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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT PROSTHESIS, ANKLE

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ZIMMER BIOMET, INC. TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT PROSTHESIS, ANKLE Back to Search Results
Model Number N/A
Device Problem Insufficient Information
Event Date 12/23/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: mfr#0001822565-2018-01784 and mfr#0001822565-2018-01786 concomitant medical products: trabecular metal total ankle tibial base component pn00830004400 ln63046939 trabecular metal total ankle tibial insert pn00830005400 ln62861441. Foreign report source- (b)(6). This product is manufactured by zimmer biomet warsaw and is cleared for export only, not for distribution in the u. S. However, this report is being submitted as zimmer biomet warsaw manufactures a similar device that is cleared or distributed in the united states under 510k number k120906. Reported event was confirmed by review of the provided x-rays and op notes. Per the op report, patient had some anterior cartilage damage, increased pain, and a cyst. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. 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.

 
Event Description

It was reported that the patient underwent an initial right ankle replacement. Subsequently, the patient suffered from recurring heterotopic ossification one year later. The patient underwent debridement and requires repeat radioablation. It was also reported the patient suffers from pain, moderate swelling/stiffness, tight laxity, gait abnormality and restriction of hindfoot motion. No plans have been made for revision at this time.

 
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Brand NameTRABECULAR METAL TOTAL ANKLE TALAR COMPONENT
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 Key7399017
Report Number0001822565-2018-01785
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00830002400
Device LOT Number62990953
OTHER Device ID NumberN/A
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 Received03/14/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/04/2015
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: 04/05/2018 Patient Sequence Number: 1
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