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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL PROXIMAL FEMORAL IMPACTOR PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. TRABECULAR METAL PROXIMAL FEMORAL IMPACTOR PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source: (b)(6). Customer has not indicated that the product will be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the product fractured during impaction. No harm was done to the patient. The surgery was finished without any problem. There is no additional information at this time.
 
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Brand NameTRABECULAR METAL PROXIMAL FEMORAL IMPACTOR
Type of DevicePROSTHESIS, KNEE
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 Key9115432
MDR Text Key160366024
Report Number0001822565-2019-04124
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110940
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00585103252
Device Lot Number61862284
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A
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