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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMORAL CR IMPACTOR PAD; INSTRUMENT, KNEE
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ZIMMER BIOMET, INC. PERSONA FEMORAL CR IMPACTOR PAD; INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and 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 impactor pad fractured during removal from the handle.There was no reported patient involvement.
 
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Brand Name
PERSONA FEMORAL CR IMPACTOR PAD
Type of Device
INSTRUMENT, KNEE
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 Key19209775
MDR Text Key341398011
Report Number0001822565-2024-01429
Device Sequence Number1
Product Code JWH
UDI-Device Identifier00889024232891
UDI-Public(01)00889024232891(10)64232957
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42509909400
Device Lot Number64232957
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/03/2024
Initial Date FDA Received04/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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