MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP PRIMARY STEM 15MM STD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.Udi # (b)(4).

Event Description

During a shoulder arthroplasty the sponge applicators were missing from the packaging which did not cause serious injury or a delay in the procedure and the stem was utilized and implanted by using a different sponges.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.The complaint sample was not returned for evaluation, and the reported event was not confirmed.The device history records were reviewed and no discrepancies were identified.Review of the bill of materials indicates the poly swab disposable was correctly issued to the order.A review of the complaint history determined that no further action is required.A root cause could not be determined.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: COMP PRIMARY STEM 15MM STD
• 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: 6094652
• MDR Text Key: 59724541
• Report Number: 0001825034-2016-04656
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113655
• Device Lot Number: 877930
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2016
• 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