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

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.

• 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 Key: 5442143
• MDR Text Key: 38379340
• Report Number: 0001825034-2016-00527
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PK070399
• Number of Events Reported: 1
• 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 Date: 08/13/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-156233
• Device Lot Number: 071430
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/08/2016; 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention