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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 52-60MM TPR INSRT-3 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM 52-60MM TPR INSRT-3 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Erosion (1214); Separation Failure (2547)
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, taperloc por fmrl 15x150, pn 103208, ln 301550, m2a-magnum pf cup 58odx52id, pn us157858, ln 722540. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00104, 0001825034-2020-00106, 0001825034-2020-00107. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the 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.
 
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
Primary right tha was performed. Patient subsequently developed elevated metal ions and noise. Attempted revision procedure; however, surgical procedure was aborted and surgical site was irrigated and closed. Patient experienced a superficial infection. Approximately 3 months later, patient underwent revision procedure due to elevated metal ion levels, metallosis, corrosion and malposition of the acetabular component. During the procedure, estimated blood loss was 1600 ml. Attempts were made to obtain additional information; however, none was available.
 
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Brand NameM2A-MAGNUM 52-60MM TPR INSRT-3
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9569832
MDR Text Key174532895
Report Number0001825034-2020-00105
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
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 Date08/31/2016
Device Model NumberN/A
Device Catalogue Number139266
Device Lot Number068770
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/09/2020 Patient Sequence Number: 1
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