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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Reaction (2414)
Event Date 05/13/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: biomet taper insert cat#139254 lot#844730, biomet head cat#157446 lot#843560, biomet cup cat#us157852 lot#151290, biomet stem cat#11-103204 lot#939100. Reported event was confirmed with medical records provided. Review of the revision operative notes confirms that the patient had right revision due to pain and elevated metal ions. Operative notes states moderate serous fluid, no purulent fluid. No corrosion. No wear or loose bodies in socket. Scar tissue excised. Review of the device history records identified no deviations or anomalies during manufacturing. A definitive root cause cannot be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. This device remains implanted in the patient. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04741.
 
Event Description
It was reported that the patient has underwent an initial right hip arthroplasty. Subsequently, the patient was revised approximately 10 years later due to metallosis. It was noted the blood serum cobalt and chromium levels were elevated. During revision non purulent serous fluid and discolored tissue was noted in the hip space. No further event information available at the time of this report.
 
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Brand NameM2A-MAGNUM PF CUP 52ODX46ID
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 Key9611295
MDR Text Key175855770
Report Number0001825034-2020-00322
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2019
Device Model NumberN/A
Device Catalogue NumberUS157852
Device Lot Number151290
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 Received01/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2009
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: 01/21/2020 Patient Sequence Number: 1
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