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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BIOMET MAGNUM M2A CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN BIOMET MAGNUM M2A CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Naturally Worn (2988)
Patient Problems Pain (1994); Local Reaction (2035); Numbness (2415); No Code Available (3191)
Event Date 11/01/2012
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: item #: unknown unknown magnum m2a head lot #: unknown. Item #: unknown unknown taperloc stem lot #: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. 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: 0001822565 - 2020 - 01243 head.
 
Event Description
It was reported that the patient had a right tha and was revised three years later due to pain, elevated metal ions, increased symptoms of parkinson¿s disease, numbness and wear. Attempts have been made and no further information has been provided.
 
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Brand NameUNKNOWN BIOMET MAGNUM M2A CUP
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 Key9920958
MDR Text Key186727341
Report Number0001822565-2020-01241
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 health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
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
Event Location No Information
Date Manufacturer Received04/28/2020
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: 04/03/2020 Patient Sequence Number: 1
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