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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK TAPERLOC MICROPLASTY STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNK TAPERLOC MICROPLASTY STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
It was reported in a journal article that 8 patients experienced stem misalignment greater than 3 mm in the short term group. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4). Country source: (b)(6). Literature source: fatih yildiz vahdet uçan, volkan ezici, orkhan aliyev, gökçer uzer & ibrahim tuncay (2021)comparison of tapered-wedge short and standard-length femoral stems in single stage bilateral direct anterior total hip arthroplasty. Https://doi. Org/10. 1007/s00264-021-05152-9. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
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Brand NameUNK TAPERLOC MICROPLASTY STEM
Type of DevicePROSTHESIS, HIP
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 Key13726300
MDR Text Key286996275
Report Number0001825034-2022-00576
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/I
Device Lot NumberN/I
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/14/2022
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 NumberN/A

Patient Treatment Data
Date Received: 03/10/2022 Patient Sequence Number: 1
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