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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 58ODX52ID PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 58ODX52ID PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Erosion (1214); Malposition of Device (2616); Noise, Audible (3273)
Patient Problems Erosion (1750); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Reaction (2414); Blood Loss (2597)
Event Date 02/27/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: m2a-magnum mod hd sz 52mm, pn 157452, ln 101240, m2a-magnum 52-60mm tpr insrt-3, pn 139266, ln 068770, taperloc por fmrl 15x150, pn 103208, ln 301550. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00104, 0001825034-2020-00105, 0001825034-2020-00106. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient became infected and had the hip irrigated and debrided on an unknown date. The patient received antibiotics for 6 weeks. Then the patient was revised approximately one year later. Findings at the time of the revision were: stem was well positioned and fixed, acetabular shell was fixed, steep and overly and anteverted, head adapter was cold welded to the stem trunnion so large head was first separated from the adaptor so the taper adaptor can be removed. The articular surface of the head shows severe corrosion as well as high cobalt levels. Attempts were made to obtain additional information; however, none was available.
 
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Brand NameM2A-MAGNUM PF CUP 58ODX52ID
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 Key9569833
MDR Text Key174533126
Report Number0001825034-2020-00107
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2016
Device Model NumberN/A
Device Catalogue NumberUS157858
Device Lot Number722540
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 Received05/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2003
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: 01/09/2020 Patient Sequence Number: 1
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