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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PLP FIBULA PLATE PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. UNKNOWN PLP FIBULA PLATE PROSTHESIS, TRAUMA Back to Search Results
Catalog Number UNKNOWN PLP FIBULA PLATE
Device Problem Corroded (1131)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 05/03/2022
Event Type  Injury  
Event Description
It was reported the patient underwent a revision surgery due to suspected corrosion from signs of skin irritation. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
(b)(4). Report source: foreign - event occurred in (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. 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.
 
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Brand NameUNKNOWN PLP FIBULA PLATE
Type of DevicePROSTHESIS, TRAUMA
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key14592296
MDR Text Key293287650
Report Number0001822565-2022-01686
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN PLP FIBULA PLATE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/08/2022
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 NumberNI

Patient Treatment Data
Date Received: 06/03/2022 Patient Sequence Number: 1
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