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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A HI CARBON MODULAR HEAD PLUS 6MM TYPE I TAPER PROSTHESIS, HIP

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BIOMET ORTHOPEDICS M2A HI CARBON MODULAR HEAD PLUS 6MM TYPE I TAPER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Swelling (2091)
Event Date 01/07/2016
Event Type  Injury  
Manufacturer Narrative
This follow-up is being submitted to relay additional information.
 
Event Description
It was reported patient had a revision procedure eleven years post-implantation due to osteolysis, metallosis, elevated metal ion levels, and pain. Additional information received in revision operative report noted corrosion material was around the metal-on-metal articulation. Corrosion was also found around the head and around the liner consistent with wear. The patient also had significant bone loss and aseptic, lymphocyte-dominated vasculitis-associated lesion (alval). Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
This 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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of medial records and x-rays provided. X-ray revealed the patient had arthritis with postol grip deformity; there was a large medial wall and inferior osteophytes. Device history record was reviewed and no discrepancies relevant to the reported event were found. 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. 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
Current information is insufficient to permit a conclusion as to the cause of the event. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 14 states ¿pain¿. Number 15 states ¿elevated metal ion levels have been reported with metal on metal articulating surfaces¿.
 
Event Description
Legal counsel for patient reported patient was revised due to unspecified allegations. This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified. Medical records reported patient¿s left hip was revised approximately ten years post-implantation due to pain, swelling and elevated ion levels.
 
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Brand NameM2A HI CARBON MODULAR HEAD PLUS 6MM TYPE I TAPER
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 Key6320932
MDR Text Key109690461
Report Number0001825034-2017-00587
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 other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2005
Device Model NumberN/A
Device Catalogue Number11-163690
Device Lot Number351920
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2005
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: 02/09/2017 Patient Sequence Number: 1
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