MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. TESS CEMENTED ANATOMIC GLENOID IMPLANT; PROTHESIS, SHOULDER

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).As biomet (b)(4) did not receive any information about the involved batch number and as the product has not been returned, biomet france was not able to perform any batch and manufacturing documentation review and product analysis could not be performed.However this event is categorized as a complaint and could be reopened if further information/product is received later.

Event Description

It has been reported that the patient has a well fixed tess humeral anatomic component.The surgeon requested a glenoid replacement, after a failed cemented anatomic glenoid implant.

• Brand Name: TESS CEMENTED ANATOMIC GLENOID IMPLANT
• Type of Device: PROTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: hélène bataille ; plateau de lautagne bp75; valence cedex 26903 ; FR 26903 ; 0334757594
• MDR Report Key: 7340695
• MDR Text Key: 102435488
• Report Number: 3006946279-2018-00095
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention