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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A TAPER 37/28MM LINER; PROSTHESIS, HIP

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BIOMET ORTHOPEDICS M2A TAPER 37/28MM LINER; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 02/02/2016
Event Type  Injury  
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 or deviation.Implanted date: (b)(6) 2001; (b)(6) 2016.Explanted date: the product was explanted on (b)(6) 2016 and reimplanted during the same procedure.There are warnings in the package insert that state that this type of event can occur: under precautions, it states, ¿do not reuse implants¿ this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-00377-1 / 00872).Remains implanted.
 
Event Description
It was reported that a patient underwent an initial right total hip arthroplasty on (b)(6) 2001.Subsequently, a revision procedure has been indicated due to the age of the implant; however, no revision procedure has been reported to date.Additional information received reported that patient underwent a revision procedure on (b)(6) 2016 due to the age of the implant and suspected loosening.During the procedure, the cup and head were removed and replaced.It was reported that the liner was removed during the revision, and then reimplanted with the new cup and head.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.
 
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Brand Name
M2A TAPER 37/28MM LINER
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 Key5503895
MDR Text Key40421456
Report Number0001825034-2016-00872
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
PK993438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/12/2016
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 Date07/31/2005
Device Model NumberN/A
Device Catalogue Number15-105000
Device Lot Number964920
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/16/2016
Initial Date FDA Received03/16/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2000
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
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