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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRX HUM HI PLT RT 3H 80MM PROSTHESIS TRAUMA

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ZIMMER BIOMET, INC. PRX HUM HI PLT RT 3H 80MM PROSTHESIS TRAUMA Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (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.
 
Event Description
It was reported that an item identified as having a hair inside the packaging during stock take. Attempts have been made and there is no further information at this time.
 
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Brand NamePRX HUM HI PLT RT 3H 80MM
Type of DevicePROSTHESIS TRAUMA
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 Key12682371
MDR Text Key277926574
Report Number0001825034-2021-02914
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K143697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 08/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number110030400
Device Lot NumberRM994L
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Date Manufacturer Received08/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
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

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