MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN COMPREHENSIVE REVERSE SHOULDER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problem No Information (3190)

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.The following could not be completed with the limited information provided.Date of event ¿ ni , device product code ¿ ni, expiration date ¿ ni, date implanted ¿ ni, date explanted ¿ ni , initial reporter ¿ ni, manufacture date ¿ ni.Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure may be necessary.Should additional information be received regarding a revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.

Event Description

Patient has been indicated for a shoulder revision due to possible rotation of the glenosphere.No revision has been reported to date.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.No device or photos were received; therefore the condition of the device is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Product history search cannot be completed since the lot number is unknown.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definite root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN COMPREHENSIVE REVERSE SHOULDER
• Type of Device: PROSTHESIS, SHOULDER
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6125744
• MDR Text Key: 60818096
• Report Number: 0001825034-2016-04878
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• 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?: No
• Date Manufacturer Received: 12/16/2016
• 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): Required Intervention