MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD W/VARIABLE OFFSET 46MM X 18MM X 53MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption and/or excessive activity." number 13 states, "intraoperative or postoperative bone fracture and/or postoperative pain.".

Event Description

Patient enrolled in a clinical study and reported right shoulder pain and subluxation of the humeral head approximately 1 month post-implantation.No revision procedure has been reported to date.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.Concomitant products: catalog #: 118001, versa-dial/comp ti std taper, lot # 615790.Catalog #: us-115736, compr nano hmrl pps 36mm, lot # 562100.Catalog #: pt-113950, pt hybrid glen post regenerex, lot # 019720.

Event Description

Patient enrolled in a clinical study and reported left shoulder subluxation of the humeral head and mild pain approximately 1 month post-implantation.No revision procedure has been reported to date.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.

Event Description

Patient enrolled in a clinical study and reported left shoulder subluxation of the humeral head forty-three days post-implantation.No revision procedure has been reported to date.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Event Description

Patient enrolled in a clinical study and reported left shoulder subluxation of the humeral head forty-three days post-implantation.Mild pain was additionally noted at three month post-operative follow-up.No revision procedure has been reported to date.

• Brand Name: VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD W/VARIABLE OFFSET 46MM X 18MM X 53MM
• 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: 5956933
• MDR Text Key: 54946764
• Report Number: 0001825034-2016-03655
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• 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,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113042
• Device Lot Number: 524540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• 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: 76 YR
• Patient Weight: 107