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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM ANKLE XL POLY INSERTS KNEE PROSTHESIS

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ZIMMER BIOMET, INC. TM ANKLE XL POLY INSERTS KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6). Reported event was confirmed by review of x-rays provided. X-ray reviewer stated subtalar and midfoot fusion. Bony fusion is noted along the medial and lateral ankle secondary to heterotopic ossification. Mild bimalleolar ankle soft tissue swelling. Osteopenia. Dhr was reviewed and no discrepancies were found. 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 patient underwent initial ankle procedure approximately four years prior. Subsequently, patient underwent observation for heterotopic ossification treatment. It was also reported the patient suffers from pain, swelling, and limited range of motion.

 
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Brand NameTM ANKLE XL POLY INSERTS
Type of DeviceKNEE 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 Key7544044
Report Number0001822565-2018-02870
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial
Report Date 05/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device MODEL NumberN/A
Device Catalogue Number00830005300
Device LOT Number62637225
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 Received05/22/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2014
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: 05/25/2018 Patient Sequence Number: 1
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