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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNK STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problems Fall (1848); Joint Dislocation (2374)
Event Date 03/04/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Cat#01000898. Liner unk head. Foreign: country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00669 and 0001825034 - 2022 - 00670.
 
Event Description
It was reported that the patient underwent an initial hip arthroplasty on an unknown date. Subsequently, the patient dislocated hip due to stem subsiding and patient fall. Patient was revised. No additional information.
 
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Brand NameUNK 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 Key13890248
MDR Text Key287836262
Report Number0001825034-2022-00671
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeAS
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 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/20/2022
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: 03/24/2022 Patient Sequence Number: 1
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