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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 PROSTHETIC, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM PROSTHETIC, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Anxiety (2328); Depression (2361); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Event Date 12/30/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant products: item number 166316 item name progressive por fmrl10x130 rt lot # 902170. Item number us157852 item name m2a-magnum pf cup52odx46id lot # 515350. Item number 139256 item name m2a-magnum 42-50 tpr insrtstd lot # 877460. The device will not be returned for analysis as location is unknown; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental mdr will be submitted.
 
Event Description
It was reported by legal that the patient underwent a right hip arthroplasty. Subsequently was revised twelve (12) years later due to pain, pseudotumor, and elevated metal ions. The shell and stem were left intact, and a dual mobility was placed without complication. 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 DevicePROSTHETIC, 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 Key11731241
MDR Text Key247478349
Report Number0001825034-2021-01169
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2018
Device Model NumberN/A
Device Catalogue Number157446
Device Lot Number848380
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 Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2008
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: 04/27/2021 Patient Sequence Number: 1
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