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 Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: compr nano hmrl pps 38mm, cat#: 115738 lot#: 648840, versa-dial/comp ti std taper, cat#: 118001 lot#: 990230, versa-dial 50x27x50 hum head, cat#: 113057 lot#: 204260, md hybrid glenoid base 4mm, cat#: 113954 lot#: 119210, pt hybrid glen post regenerex generex, cat#: pt-113950 lot#: 792590.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 varying times spanning from two (2) days to one (1) year post-operatively.Signs of humeral osteolysis were also 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

Reported event was confirmed by review of x-rays provided.Visual observation of the provisional confirmed that both screw heads were at, or below flush prior to disassembly.One of the hex features stripped on a screw while trying to disassemble.Dimensions taken are within spec.X-ray reviewer stated "periprosthetic lucencies wax and wane at different time points.Interestingly initial detection is 2 days after initial imaging at which no periprosthetic lucency was clearly discernable (i.E.Between (b)(6) 2014).Although the abnormal lucency continues to extend laterally through (b)(6) 2015, the bone begins to mineralize on (b)(6) 2015 and the lucency begins to become less apparent.However on the last time point, at least on ap views, the lucencies are more readily apparent." device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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: 6672646
• MDR Text Key: 78552655
• Report Number: 0001825034-2017-04397
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 407258
• Device Lot Number: 848310
• 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
• Initial Date Manufacturer Received: 05/29/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2011
• 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: 66 YR
• Patient Weight: 84