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)(6).Concomitant medical product: compr nano hmrl pps 36mm, cat#: 115736 lot#: 648820; versa-dial/comp ti std taper, cat# 118001 lot#: 764220; versa-dial 50x21x57 hum head, cat#: 113053 lot#: 833450; md hybrid glenoid base 4mm, cat#: 113954 lot#: 678430; pt hybrid glen post regenerex, cat#: pt-113950, lot# 461240.Customer has indicated that the device is in the process of being returned to zimmer biomet (b)(4) 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 approximately six (6) weeks and six (6) months post-operatively.Humeral osteolysis was additionally 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 by review of x-rays provided.Provisional head is returned for evaluation.Dimensions taken are within specifications 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.Both hex features stripped on the screws while trying to disassemble.Dhr was reviewed and no discrepancies were found.There are warnings in the package insert that this type of event can occur and risks are addressed in the associated risk documentation.X-ray review show first two time points appear unremarkable without periprosthetic lucencies.However, on the last time point, slightly less than 6 months from original imaging, a well demarcated periprosthetic lucency is seen distal to the central portion of the humeral hardware component.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Review of the complaint history determined that no further action is required 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: 6672619
• MDR Text Key: 78547429
• Report Number: 0001825034-2017-04376
• 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: 11/02/2017

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: 407254
• Device Lot Number: ZB110901
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 80