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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Numbness (2415); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown. The investigation is in process. Once the investigation has been completed, follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00725, 0001822565 - 2021 - 00726, 0001822565 - 2021 - 00727.
 
Event Description
It was reported that patient is experiencing severe pain, swelling and numbness with pinching and pins, needles all down the leg after an unknown amount of time post right total hip arthroplasty. No revision surgery or medical intervention 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 NameUNKNOWN 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 Key11494500
MDR Text Key240040866
Report Number0001822565-2021-00728
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/18/2021
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: 03/16/2021 Patient Sequence Number: 1
Treatment
UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN LINER
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