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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Burning Sensation (2146); Metal Related Pathology (4530); Solid Tumour (4552); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Implant date: unknown month and day in 2006. The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress. 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: 0001825034-2022-00086, 0001825034-2022-00088.
 
Event Description
It was reported that approximately 15 years post implantation, the patient is experiencing severe burning, pain, and massive swelling due to the metal on metal hip that is causing swelling of her joints. Orthopedic surgeon has aspirated to remove the metal debris/blood collection. The surgeon recently told her after having recent surgery to partially remove a massive tumor that is being caused by the hip that her anatomy is being eaten away from the metal. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameM2A-MAGNUM MOD HD SZ 46MM
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 Key13237617
MDR Text Key283748345
Report Number0001825034-2022-00087
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2016
Device Model NumberN/A
Device Catalogue Number157446
Device Lot Number160170
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2006
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: 01/12/2022 Patient Sequence Number: 1
Treatment
CAT#: US157852 M2A CUP LOT#: 180314; UNKNOWN TAPER ADAPTER
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