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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification were not provided for the patients mentioned in the journal article.This is number 2 of 2 mdrs filed for the same events (reference 1825034-2016-01732 and 3006946279-2016-00096).

Event Description

Information was received based on a review of the journal article, "association of lateral humeral offset with functional outcome and geometric restoration in stemless total shoulder arthroplasty." the aims of this study were to determine the association of postoperative lateral humeral offset (lho) changes with shoulder function and quality of life and to investigate the ability of stemless anatomic total shoulder arthroplasty to restore lho, humeral head height (hh), center of rotation (cor), and neck-shaft angle (nsa).The hypothesis was that postoperative lho changes would influence shoulder function and quality of life and the stemless anatomic total shoulder arthroplasty (tsa) would restore the tested geometric parameters to acceptable limits.Two patients identified in the article were reported to have experienced post-traumatic osteoarthritis following implantation of the device.

• Brand Name: UNKNOWN EXTREMITY
• Type of Device: PROSTHESIS, 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: elisabeth plane ; plateau de lautagne bp75; valence cedex 26903 ; FR 26903 ; 0334757591
• MDR Report Key: 5685937
• MDR Text Key: 46159321
• Report Number: 3006946279-2016-00096
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other