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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A HI CARBON TAPER LINER PROSTHESIS, HIP

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BIOMET ORTHOPEDICS M2A HI CARBON TAPER LINER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Pain (1994)
Event Date 06/24/2016
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed. Device history record was reviewed and no discrepancies relevant to the reported event were found. Review of complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined. There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation. 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
Hip revision due to pain, elevated ion levels, pseudotumor, and cystic debris. Metal debris was identified around the acetabulum.
 
Manufacturer Narrative
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. This report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2016-02706 and 0001825034-2017-00347).
 
Event Description
It was reported that patient underwent a right hip revision procedure approximately 8 years post-implantation due to pain. During the procedure, the femoral head, acetabular liner and cup were removed and replaced. Additional information received in medical records confirmed the patient¿s right hip was revised approximately 8 years post-implantation due to pain. Operative report indicates the presence of a pseudotumor, elevated metal ion levels and cystic debris.
 
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Brand NameM2A HI CARBON TAPER LINER
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 Key6294922
MDR Text Key109836769
Report Number0001825034-2017-00347
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2017
Device Model NumberN/A
Device Catalogue Number15-105044
Device Lot Number006440
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 Received08/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2007
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: 02/01/2017 Patient Sequence Number: 1
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