MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL SHOULDER SYSTEM HUMERAL HEAD TRIAL; TEMPLATE

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: compr nano hmrl pps 32mm, cat#: 115732 lot#: 100260, versa-dial/comp ti std taper, cat#: 118001 lot#: 984300, versa-dial 46x24x47 hum head, cat#: 113046 lot#: 135050, sm hybrid glenoid base 4mm, cat#: 113952 lot#: 627200, pt hybrid glen post regenerex, cat#: pt-113950 lot#: 630080.Customer has indicated that the device is in the process of being returned to zimmer biomet warsaw for evaluation.The investigation is in process.Once the investigation has been completed, a follow-up medwatch will be submitted.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

It was reported that a patient underwent a right shoulder arthroplasty.Subsequently, humeral component radiolucency was noted at four (4) different follow-up times spanning from four (4) months to one (1) year post-operatively, however no progression of the radiolucency has been noted.The initial surgeon noted there was a gap present between the humeral component and humeral head implant during the initial procedure, due to an issue with a discrepancy between the trial head representation and the definitive humeral head implant.The surgeon states this may be leading to the radiolucency.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed based on the x-ray review.Dimensions taken are within spec as documented on the attached prints and gage data sheet.Visual observation confirmed that both screw heads were at, or below flush prior to disassembly.X-ray reviewer stated "the radiolucent zones around the hardware are likely related to the native mineralization or postoperative changes in the humerus.The lucent zone measures approximately 2.5 mm on all time points".Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.

• Brand Name: VERSA-DIAL SHOULDER SYSTEM HUMERAL HEAD TRIAL
• Type of Device: TEMPLATE
• 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: 6672643
• MDR Text Key: 78552193
• Report Number: 0001825034-2017-04398
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• 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: 407246
• Device Lot Number: 176000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 70