MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 10/18/2016

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 10 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.".

Event Description

Patient underwent a shoulder revision 5 years post-implantation due to the taper of the glenoid baseplate fracturing from the base.The taper, glenoid baseplate and humeral bearing were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Complaint sample was evaluated and the reported event was not confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Medical product- biomet comprehensive reverse shoulder glenosphere baseplate catalog#: 115330 lot#: 831260, biomet comprehensive locking screw catalog#: 180502 lot#:516290, biomet comprehensive reverse screw catalog#: 115380 lot#: 552650, biomet comprehensive locking screw catalog#: 180502 lot#: 186940, biomet comprehensive locking screw catalog#: 180501, lot#: 609490, comprehensive reverse shoulder glenosphere catalog#: 115310 lot#: 792370, versa-dial taper catalog#: 118001 lot#: 602730, biomet comprehensive primary stem catalog#: 113654 lot#: 582540, biomet humeral bearing catalog#: xl-115363 lot#: 116180.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.Corrected: (describe event or problem).

Event Description

Patient underwent a shoulder arthroplasty revision approximately five years post-implantation due to the taper of the humeral tray fracturing from the base.The fractured taper was removed and the humeral tray and humeral bearing were replaced.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44MM
• 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: 6095491
• MDR Text Key: 59719130
• Report Number: 0001825034-2016-04671
• 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,Followup
• Report Date: 03/20/2017

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: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 118250
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/17/2017; 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2010
• 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