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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 56ODX50ID; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 56ODX50ID; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Erosion (1750); Pain (1994); Local Reaction (2035); Tissue Damage (2104)
Event Date 05/30/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01812.
 
Event Description
It was reported patient underwent hip revision approximately 8 years post implantation due to a pseudotumor, metal on metal, altr, and pain.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records identified no related deviations or anomalies during manufacturing.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated.Device was returned and evaluated.Upon visual inspection, the cup has scuffing on the inside radius.The additional information does not change the outcome of the previous investigation.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.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
M2A-MAGNUM PF CUP 56ODX50ID
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8549158
MDR Text Key143050600
Report Number0001825034-2019-01813
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2019
Device Model NumberN/A
Device Catalogue NumberUS157856
Device Lot Number313690
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Was the Report Sent to FDA? No
Date Manufacturer Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
BIOMET BI-METRIC/X POR NC CAT#X180313 LOT#750290; BIOMET M2A HEAD CATALOG#157450 LOT#534480; BIOMET M2A MAGNUM TPR INSRT CAT#139258 LOT#467350; BIOMET BI-METRIC/X POR NC CAT#X180313 LOT#750290; BIOMET M2A HEAD CATALOG#157450 LOT#534480; BIOMET M2A MAGNUM TPR INSRT CAT#139258 LOT#467350
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age61 YR
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