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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EPOLY 36MM RNGLC LINER HW SZ25; PROSTHESIS, HIP

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BIOMET ORTHOPEDICS EPOLY 36MM RNGLC LINER HW SZ25; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Date 05/02/2014
Event Type  Injury  
Event Description
It was reported patient underwent right total hip arthroplasty (b)(6) 2013.Subsequently, patient underwent procedures on (b)(6) 2014 and (b)(6) 2014 due to infection.The liners were removed and replaced.
 
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.Follow up attempts to obtain additional information pertaining to event details and product identification are in process.Should additional information be received, biomet will forward a supplemental report to the fda.The following sections could not be completed with the limited information provided.Lot number and expiration date - unknow.Manufacture date ¿ unknown.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-04768, 4772).
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
 
Event Description
It was reported that a patient enrolled in a clinical study underwent right total hip arthroplasty on (b)(6) 2013.A revision procedure was performed on (b)(6) 2014 due to infection and the acetabular liner was replaced.Another revision procedure took place on (b)(6) 2014 due to ongoing infection where the acetabular liner and modular head were replaced.A subsequent revision procedure occurred on (b)(6) 2014 to replace the liner and head with a constrained system due to dislocation.A debridement procedure took place on (b)(6) 2014 where the acetabular liner was also revised due to infection.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
 
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Brand Name
EPOLY 36MM RNGLC LINER HW SZ25
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
amanda zajicek
56 e. bell drive
warsaw, IN 46582
5743726782
MDR Report Key3829986
MDR Text Key4395356
Report Number0001825034-2014-04772
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
PK070399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/16/2014
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 Model NumberN/A
Device Catalogue NumberEP-105915
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/16/2014
Initial Date FDA Received05/23/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received07/21/2014
12/30/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Age54 YR
Patient Weight125
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