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 40mm, cat#: 115740 lot#: 893940, versa-dial 50x24x52 head prov, cat#: 407256 lot#: unknown, versa-dial/comp ti std taper, cat#: 118001 lot#: 118390, versa-dial 50x24x52 hum head, cat#: 113055 lot#: unknown, md hybrid glenoid base 4mm, cat#: 113954 lot#: 71720, pt hybrid glen post regenerex, cat#: pt-113950 lot#: 520.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 left shoulder arthroplasty.Subsequently, humeral component radiolucency was noted at six (6) weeks, six (6) months, and one (1) year post-operatively.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 filed to relay additional information, which was unknown at the time of the initial medwatch.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.

Manufacturer Narrative

Reported event of radiolucency was confirmed by review of x-rays.The alleged mismatch of the trial head to the definitive implant contributing to the radiolucency could not be confirmed.X-ray reviewer stated "the assumed left shoulder hardware is present with a periprosthetic lucency located inferior to the central portion of the hardware measuring a maximum amount of 11 x 7.2 mm (tv x cc)." provisional humeral head is returned for evaluation.Visual observation confirmed that both screw heads were at, or below flush prior to disassembly.Visually the parts have very little wear.Dimensions taken are with specifications.Unable to locate dhr for the part 407256 and lot 848290 combination.Upon review of design documentation, it is concluded the versa-dial provisionals and implants used in the comprehensive nano total shoulder replacement were designed as intended.The mismatch between the provisional humeral head and versa dial implant head was substantiated; however, based on the investigation the devices performed as intended.The root cause of radiolucency cannot be determined with the information 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: 6672641
• MDR Text Key: 78549437
• Report Number: 0001825034-2017-04375
• 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,Followup
• Report Date: 02/22/2018

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: 407256
• Device Lot Number: 848290
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2010
• 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: 68 YR
• Patient Weight: 83