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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MAGNUM TAPER ADAPTER; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. M2A MAGNUM TAPER ADAPTER; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Pain (1994); Toxicity (2333); No Code Available (3191)
Event Date 01/25/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Medical product: modular taperloc femoral, catalog#: 103203, lot#: 436980.M2a magnum pf cup, catalog#: us157850, lot#: 107270.M2a magnum modular head, catalog#: 157444, lot#: 700730.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-09934, 09935.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
It was reported that during revision surgery, the taper was found to be cold-welded to the stem.Due to the issue, the stem became loose during attempts to separate the devices intra-operatively, and had to be removed.No further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.During the revision procedure it was noted that the neck was cold-welded to the stem.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.
 
Event Description
It was reported that during revision surgery, the taper was found to be cold-welded to the stem.Due to the issue, the stem became loose during attempts to separate the devices intra-operatively, and had to be removed.No further information has been provided.
 
Manufacturer Narrative
The follow-up report is being submitted to relay additional information.  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
It was reported that the patient suffered from metal poisoning.
 
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Brand Name
M2A MAGNUM TAPER ADAPTER
Type of Device
PROSTHESIS, 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 Key7001329
MDR Text Key91023121
Report Number0001825034-2017-09934
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date06/30/2020
Device Model NumberN/A
Device Catalogue Number139258
Device Lot Number440960
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2010
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
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