MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVRS HUM BRG/TRAY TRIAL 44STD-36STD; KNEE INSTRUMENTATION, CONDYLAR

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 07/04/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a reverse shoulder procedure on (b)(6) 2014.During the procedure, the humeral trial dislocated while trialing the components.The procedure was completed without a delay.

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.(b)(4).

Manufacturer Narrative

Evaluation of the returned device found the part left biomet in a conforming condition and it appears that the stem taper length may have contributed to the fracture.An engineering change has been initiated to reduce the stem taper length in order to mitigate the possibility of fracture during use.Review of device history records show that lot released with no recorded anomaly or deviation.

Event Description

It was reported that patient underwent a reverse shoulder procedure on (b)(6) 2014.During the procedure, the humeral trial fractured while trialing the components.The fractured pieces were retrieved from the patient and the procedure was completed without a delay.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

• Brand Name: COMP RVRS HUM BRG/TRAY TRIAL 44STD-36STD
• Type of Device: KNEE INSTRUMENTATION, CONDYLAR
• 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: 3964427
• MDR Text Key: 4606563
• Report Number: 0001825034-2014-06483
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 405940
• Device Lot Number: ZB120701
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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): Required Intervention