MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVRS SHLDR GLNSP STD 41MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 03/18/2013

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 the lot released with no recorded anomaly or deviation.In the package insert under possible adverse effects, item 4 states: "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption and/or excessive activity." concomitant medical product - comp primary stem 16mm std catalog #: 113656 lot #: 110350, comp locking screw catalog #: 180501 lot #: 710430, comp non-lckng screw catalog #: 180509 lot #: 999860, comp rvrs shdr glen bsplt catalog #: 115330 lot #: 628500, comp non-lckng screw catalog #: 180508 lot #: 979470, comp rvs cntrl scr catalog #: 115381 lot #: 345270.This is 5 of 5 reports being filed for the same patient (reference 1825034-2017-00721 - 00725).

Event Description

It is reported that the shoulder was revised due to instability approximately 4 months post-implantation.

• Brand Name: COMP RVRS SHLDR GLNSP STD 41MM
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6340588
• MDR Text Key: 67722523
• Report Number: 0001825034-2017-00725
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 115320
• Device Lot Number: 410690
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2010
• 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: 76 YR