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U.S. Department of Health and Human Services

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

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BIOMET ORTHOPEDICS M2A TAPER LINER 32MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Metal Shedding Debris (1804); Improper Chemical Reaction (2952)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); No Code Available (3191)
Event Date 01/26/2015
Event Type  Injury  
Event Description
It was reported the patient underwent a total hip arthroplasty on (b)(6) 2003.Subsequently, the patient was revised on (b)(6) 2015 due to a reaction to metal debris.All components were removed and replaced.
 
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "material sensitivity reactions." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-00448 / 00449).
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions." number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." this report is number 1 of 3 mdrs filed for the same event (reference 1825034-2015-00448 / 00449 & 2017-00083).
 
Event Description
Patient underwent a left hip revision procedure approximately 12 years post-implantation due to left hip pain, decreased range of motion, and reaction to metal debris.During the revision, well-fixed femoral and acetabular components, significant erosion of the greater trochanter, and corrosion at the head-taper junction were noted.All components were removed and replaced and a poly bearing was implanted.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Concomitant medical products: pn: 10-104052, ln: 382360, m2a-t m/h rad 2hl shl.Pn: 162311, ln: 646440, bi-metric porous fmrl.
 
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Brand Name
M2A TAPER LINER 32MM
Type of Device
PROSTHESIS, 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
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key4478646
MDR Text Key5325830
Report Number0001825034-2015-00448
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 Company Representative,company representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date07/31/2013
Device Model NumberN/A
Device Catalogue Number15-105004
Device Lot Number485780
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/23/2015
Initial Date FDA Received02/03/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received01/12/2017
01/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2003
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) Hospitalization; Required Intervention;
Patient Age53 YR
Patient Weight102
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