MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL 42X18X46 HUMERAL HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2016

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 or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, #5.Loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption and/or excessive activity.(b)(4).

Event Description

Post-operative x-rays taken approximately one year post-implantation indicate slight proximal migration of the humeral head of left total shoulder arthroplasty.

Manufacturer Narrative

Concomitant medical product: hybrid glenoid base, catalog#: 113954, lot#: 310890.Hybrid glenoid porous titanium glenoid post regenerex, catalog#: pt-113950, lot#: 166530.Comprehensive shoulder system mini humeral stem, catalog#: 113630, lot#: 951160.Comprehensive shoulder system standard taper adaptor, catalog#: 118001, lot#: 367140.Reported event was confirmed by review of medical records provided.Medical records report slight proximal migration of the humeral head on x-ray.X-ray review also indicates progressive radiolucency in zones 1, 2, 3, 4, 5, and 6.Device history record (dhr) was reviewed and showed the lot released with no deviations or anomalies.Review of the complaint history determined that no further action(s) is/are required.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.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2017-00314, 03538, 03539.

Event Description

It is reported that slight proximal migration of the humeral head was found on x-ray approximately 12 months post left left shoulder replacement implantation.X-ray review also indicates progressive glenoid component radiolucency in zones 1, 2, 3, 4, 5, and 6.Patient was asymptomatic.No revision has been reported.

• Brand Name: VERSA-DIAL 42X18X46 HUMERAL HEAD
• 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: 6292645
• MDR Text Key: 66244854
• Report Number: 0001825034-2017-00314
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• 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: 113032
• Device Lot Number: 980550
• Other Device ID Number: SEE NARRARTIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2015
• 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): Other
• Patient Age: 62 YR
• Patient Weight: 82