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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERIARTICULAR PLATE; PLATE, FIXATION
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ZIMMER BIOMET, INC. UNKNOWN PERIARTICULAR PLATE; PLATE, FIXATION Back to Search Results
Device Problem Corroded (1131)
Patient Problem Failure of Implant (1924)
Event Date 12/10/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
 
Event Description
It was reported that the patient was revised.Corrosion was noted at the plate-screw interface.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause could not be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
UNKNOWN PERIARTICULAR PLATE
Type of Device
PLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11603435
MDR Text Key243408827
Report Number0001822565-2021-00930
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN PERIARTICULAR SCREW.; UNKNOWN PERIARTICULAR SCREW
Patient Outcome(s) Hospitalization; Required Intervention;
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