MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPR SRS MOD STEM - 8X75MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 11/25/2014

Event Type  Injury  

Event Description

It was reported patient underwent a comprehensive shoulder arthroplasty on (b)(6) 2014.Subsequently, patient underwent a revision procedure on (b)(6) 2014 due to disassociation of the versa-dial head from the proximal body.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "disassociation of the humeral head component from the humeral stem component has been reported.Failure to properly align and completely seat the components together can lead to disassociation." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-09012 / 09013).

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.(b)(4).

Event Description

It was reported patient underwent a comprehensive right shoulder arthroplasty on (b)(6) 2014.Subsequently, patient underwent a revision procedure on (b)(6) 2014 on the right side due to disassociation of the versa-dial head from the proximal body.Review of invoice history confirms the initial procedure date and shows that the versa-dial head and the stem were removed and replaced on (b)(6) 2014.

• Brand Name: COMPR SRS MOD STEM - 8X75MM
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4323260
• MDR Text Key: 5213640
• Report Number: 0001825034-2014-09013
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 211231
• Device Lot Number: 046210
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2012
• 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