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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 52MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 52MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Reaction (2414)
Event Date 10/18/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. Concomitant medical products: item number: us157858, item name: m2a-magnum pf cup 58odx52id, lot #: 871440. Item number: 13-103206, item name: taperloc por red/lat 12. 5x145, lot #: 972280. Item number: 139264, item name: m2a-magnum 52-60mm tpr insrt-6, lot #: 263510. Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2018-10721. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient was revised approximately 9 years post-implantation due to "metalosis" and erosion of the proximal femur. During revision surgery extensive metallosis in serum, a "psuedotumor", erosion of the proximal femur, and a fluid collection was noted. It was also noted that the hip was difficult to dislocate during revision surgery. No additional information is available at this time.
 
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Brand NameM2A-MAGNUM MOD HD SZ 52MM
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 Key8103633
MDR Text Key128332865
Report Number0001825034-2018-10722
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 health professional,other
Reporter Occupation
Type of Report Initial
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number157452
Device Lot Number541690
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 Received10/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2008
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: 11/26/2018 Patient Sequence Number: 1
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