MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. UNKNOWN TESS IMPLANT; SHOULDER PROSTHESIS

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 03/31/2017

Event Type  Injury  

Event Description

It was reported that the patient underwent shoulder revision surgery due to subscapularis tendon insufficiency.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G2-foreign- france.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).Upon review of this complaint from an investigation perspective, it is now considered that the tess glenoid insert within this complaint does not impact the reported event of subscapularis tendon insufficiency.Given the above information this medwatch will be voided.

Event Description

Upon review of this complaint from an investigation perspective, it is now considered that the tess glenoid insert within this complaint does not impact the reported event of subscapularis tendon insufficiency.Hence this report will be voided.

• Brand Name: UNKNOWN TESS IMPLANT
• Type of Device: SHOULDER PROSTHESIS
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18118372
• MDR Text Key: 327907978
• Report Number: 3006946279-2023-00094
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 12/15/2023
• 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 Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 46 KG