MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN EXTREMITY

Model Number N/A

Device Problem Sticking (1597)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 09/18/2015

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.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.

Event Description

It was reported a patient underwent a comprehensive hemi shoulder arthroplasty on an unknown date.Subsequently, the patient was revised to a reverse shoulder on (b)(6) 2015 due to torn rotator cuff.Due to tightness of shoulder, the stem had to be removed and re-cut to accommodate a new stem and the reverse components.No further information has been provided.

• Brand Name: UNKNOWN EXTREMITY
• Type of Device: UNKNOWN
• 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: 5142313
• MDR Text Key: 28034465
• Report Number: 0001825034-2015-04259
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN EXTREMITY
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2015
• 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