MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOM XL 44-36 RTNV+3 HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 03/25/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent total shoulder arthroplasty on an unknown date.Subsequently, patient underwent multiple revisions in a three week time period due to recurrent dislocations.

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.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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 possible adverse effects, number 9 states, "dislocation and subluxation due to inadequate fixation and improper positioning." this report is number 1 of 4 mdrs filed for the same event (reference 1825034-2015-02128 & 02610 / 02612).

Event Description

It was reported that patient underwent a reverse total shoulder arthroplasty on (b)(6) 2015.Subsequently, patient underwent three revision procedures on (b)(6) 2015, (b)(6) 2015 and (b)(6) 2015 due to recurrent dislocation.

• Brand Name: ARCOM XL 44-36 RTNV+3 HUMERAL BEARING
• 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: 4788817
• MDR Text Key: 21843364
• Report Number: 0001825034-2015-02128
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• 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
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: XL-115365
• Device Lot Number: 457890
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR