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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM CEMENTLESS COLLARLESS HIGH OFFSET 12/14 TAPER SIZE 6 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. FEMORAL STEM CEMENTLESS COLLARLESS HIGH OFFSET 12/14 TAPER SIZE 6 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Necrosis (1971)
Event Date 04/04/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical product: cat#00-8755-052-02 shell lot#3097158; cat#00-8775-010-36 liner lot#3087512; cat#00-8775-036-02 head lot#3095862. Source: foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient underwent initial hip arthroplasty. Subsequently the patient experienced necrosis and loss of activity approximately one year post implantation. Review of ct scan shows possible implant fracture. No revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameFEMORAL STEM CEMENTLESS COLLARLESS HIGH OFFSET 12/14 TAPER SIZE 6
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 Key14141006
MDR Text Key289500786
Report Number0001825034-2022-00922
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K182048
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
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number574102060
Device Lot Number3066887
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/04/2022
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: 04/19/2022 Patient Sequence Number: 1
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