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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN TIMESH

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BIOMET ORTHOPEDICS UNKNOWN TIMESH Back to Search Results
Model Number N/A
Device Problem Biocompatibility (2886)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. 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.
 
Manufacturer Narrative
This report is being submitted to relay corrected information. Upon reassessment, it was found that this product does not fall under the reporting responsibility of this company. This record should be voided.
 
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has dissolved. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It is reported that the patient underwent a procedure with times. Subsequently the product is alleged to have disintegrated in the patient's abdominal wall. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN TIMESH
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6443315
MDR Text Key109124098
Report Number0001825034-2017-02245
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2017
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: 03/29/2017 Patient Sequence Number: 1
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