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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A 32MM TAPER SYSTEM PROSTHESIS, HIP

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BIOMET ORTHOPEDICS M2A 32MM TAPER SYSTEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problem Reaction (2414)
Event Date 05/19/2015
Event Type  Injury  
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 (dhr) for the head and taper liner identified no deviations or anomalies. Metal on metal complaints will be monitored through monthly post market surveillance trending process. The reported components were reviewed for compatibility with no issues noted. Without the opportunity to examine the complaint product, root cause of the reported event cannot be determined. No corrective actions, preventive actions, or field actions resulted after investigation of this event. A summary of the investigation has been sent to the complainant. If any further information is found which would change or alter any conclusions or information, a supplemental will be filled accordingly. Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
(b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Concomitant medical products- biomet m2a universal shell, catalog#: 15-103682, lot#: 646000. Biomet taperlock, catalog#: 11-103206, lot#: 996730. Multiple mdr reports were filed for this event. 0001825034-2017-02262, 0001825034-2017-02263.
 
Event Description
It was reported patient underwent a right hip revision procedure approximately seven years post-implantation due to metal sensitivity. The femoral head was revised.
 
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Brand NameM2A 32MM TAPER SYSTEM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6464355
MDR Text Key109783836
Report Number0001825034-2017-02263
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK003363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 08/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Model NumberN/A
Device Catalogue Number11-163688
Device Lot Number531550
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2008
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: 04/06/2017 Patient Sequence Number: 1
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