MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP LK SCR 3.5HEX 4.75X35 ST; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Fitting Problem (2183)

Patient Problem Unspecified Infection (1930)

Event Date 09/03/2015

Event Type  Injury  

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 or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, it states, ¿improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.¿ this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-04119 / 04120).

Event Description

It was reported that the patient had an initial shoulder procedure on an unknown date.Subsequently, the patient was revised due to infection on an unknown date.The patient underwent another shoulder procedure on (b)(6) 2015.During the procedure, the poly would not fit into the baseplate as the locking screws were sitting too proud in the baseplate.The surgeon removed the screws and repositioned a few times.The procedure was completed with shorter screws.This caused a delay of 30 minutes.Additionally, while impacting the poly the surgeon fractured the impactor and pieces fell into the patient.The fracture pieces we retrieved from the patient.

Manufacturer Narrative

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

• Brand Name: COMP LK SCR 3.5HEX 4.75X35 ST
• 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: 5112211
• MDR Text Key: 27057428
• Report Number: 0001825034-2015-04119
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK132239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 180554
• Device Lot Number: 329580
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• 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
• Patient Age: 54 YR
• Patient Weight: 132