• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EPOLY 36MM RLC LNR +5 SZ23; PROSTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET ORTHOPEDICS EPOLY 36MM RLC LNR +5 SZ23; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Component or Accessory Incompatibility (2897)
Patient Problem No Information (3190)
Event Date 01/19/2016
Event Type  Injury  
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.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.
 
Event Description
It was reported that the patient underwent a total hip arthroplasty on (b)(6) 2016.During the procedure, the acetabular liner would not fully seat into the acetabular liner.This resulted in a 60 minute delay in the procedure.Another acetabular liner was used to complete the procedure.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.Review of the device could not confirm the reported complaint.A definitive root cause cannot be determined with the information provided.
 
Manufacturer Narrative
This follow-up report is being filed to relay corrected information.
 
Event Description
It was reported that the patient underwent a total hip arthroplasty on (b)(6), 2016.During the procedure, the acetabular liner would not fully seat into the acetabular cup.This resulted in a 60 minute delay in the procedure.Another acetabular liner was used to complete the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EPOLY 36MM RLC LNR +5 SZ23
Type of Device
PROSTHESIS, KNEE
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 Key5442143
MDR Text Key38379340
Report Number0001825034-2016-00527
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
PK070399
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,Followup
Report Date 04/21/2016
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 Date08/13/2020
Device Model NumberN/A
Device Catalogue NumberEP-156233
Device Lot Number071430
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/20/2016
Initial Date FDA Received02/17/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received04/08/2016
04/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2015
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;
-
-