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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TIBAL BASE PROSTHESIS, ANKLE

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ZIMMER BIOMET, INC. UNKNOWN TIBAL BASE PROSTHESIS, ANKLE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Date 05/08/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: item #: pm0001517 penny rt talus sz 2, lot #: 272150; item #: unknown, unknown tibal insert, lot #: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01032, 0001825034 - 2021 - 01035.
 
Event Description
It was reported by patient's legal counsel that the patient underwent a right ankle procedure. The initial pmi device requested was for the left side and was not usable for this procedure. Spacers were placed and a right pmi device was ordered mirrored from the left ankle scans. Initial implantation completed a month later. Legal counsel is reporting patient has filed an allegation claiming pain, stiffness, ambulatory issues and scarring. No revision has been reported at this time. No additional information is available at this time.
 
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Brand NameUNKNOWN TIBAL BASE
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 Key11658099
MDR Text Key245508874
Report Number0001825034-2021-01034
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/18/2021
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/13/2021 Patient Sequence Number: 1
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