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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 Problems Material Erosion (1214); Separation Failure (2547); Insufficient Information (3190); Noise, Audible (3273)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994); Swelling (2091)
Event Date 12/28/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: m2a-magnum 52-60mm tpr insrt-3, pn 139266, ln 068770, m2a-magnum pf cup 58odx52id, pn us157858, ln 722540, taperloc por fmrl 15x150, pn 103208, ln 301550. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00102, 0001825034-2020-00103. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. 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 underwent an initial surgery and began experiencing pain and squeaking of the hip as well as elevated ion levels. Revision of the hip was attempted approximately 8 years after the initial surgery, but the head could not be removed. The surgery was aborted and the implant was retained. 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 performed. Patient subsequently developed elevated metal ions and noise. Attempted revision procedure occurred 9 years later, and unable to disengage femoral head, surgical procedure was aborted and surgical site was irrigated and closed. Approximately 1 week post aborted procedure, patient developed fever and superficial surgical site infection. I&d of surgical site performed 9 days later, no components removed. Patient received iv antibiotic treatment.
 
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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
MDR Report Key9563790
MDR Text Key174167633
Report Number0001825034-2020-00101
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 company representative,distri
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 Received01/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number157452
Device Lot Number101240
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/08/2020 Patient Sequence Number: 1
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