MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE 25MM BASEPLATE HA+ADPTR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

It was reported that patient underwent reverse shoulder arthroplasty on (b)(6) 2014.During the procedure, the packaging for the baseplate was opened and the adapter was missing from the package.A second package of the same lot was opened and the adapter was missing.A third adapter was available to complete the procedure without significant delay.There was no injury to the patient as a result.

Manufacturer Narrative

Decision was made to recall based on an investigation which identified that the taper adapters were not issued to the order and packaged with the baseplates for this lot.This could result in a delay to a surgical procedure as another taper adapter would have to be retrieved for use with the baseplate.Reference 1825034-2014-012r.Two baseplates of this lot were opened and found to be missing the adaptor.The first baseplate was implanted with another taper adapter that was available during the procedure.

• Brand Name: COMPREHENSIVE REVERSE 25MM BASEPLATE HA+ADPTR
• 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: 4414015
• MDR Text Key: 5370420
• Report Number: 0001825034-2015-00018
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 010000589
• Device Lot Number: 527400
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1825034-2014-012R
• Patient Sequence Number: 1
• Patient Age: 83 YR