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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E1 RINGLOC BIPOLAR 28X51MM; PROSTHESIS, HIP

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BIOMET ORTHOPEDICS E1 RINGLOC BIPOLAR 28X51MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Component or Accessory Incompatibility (2897)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/07/2016
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 the lot released with no recorded anomaly or deviation.Pma 510(k): - this product is not cleared or distributed in the u.S., however, this report is being submitted as a similar device is cleared in the united states under 510k number k051569.Examination of returned device found no evidence of product non-conformance and a conclusive root cause could not be determined.
 
Event Description
During a total hip arthroplasty, the surgeon was not satisfied with the articulation between the acetabular component and femoral head.The components were removed and replaced to complete the procedure.
 
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Brand Name
E1 RINGLOC BIPOLAR 28X51MM
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 Key5919542
MDR Text Key53660370
Report Number0001825034-2016-03413
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 08/25/2016
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? Yes
Device Operator Physician
Device Expiration Date03/31/2019
Device Model NumberN/A
Device Catalogue Number110010462
Device Lot Number661820
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/25/2016
Initial Date FDA Received08/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2014
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) Required Intervention;
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