MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE VRS GLENOID W/FAST GUIDES; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number N/A

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906); Device Operational Issue (2914)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product classification code = phx.Udi number - (b)(4).The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.

Event Description

It was reported that the patient underwent initial surgery with a comprehensive vrs shoulder system.During the procedure, as the doctor drilled and implanted peripheral screws to secure the implant, he was unable to implant the central screw, either due to the screw hole or the glenoid component itself.The surgeon also tried a second time, without success.Ultimately, the component was implanted without the central screw.It was further reported that the central guide does not fit well inside the central hole of the custom glenoid, furthermore the guide that comes with the glenoid is situated on the wrong side making use difficult because of exposure within the shoulder, thus contributing to this issue.Attempts have been made to obtain additional information however further information is not available at this time.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional information.Concomitant medical products: comp rvs cntrl 6.5 x 30 mm st/rst lot#911190 item#115396.The reported event could not be confirmed based on limited information received.No devices returned; therefore, no visual or dimensional inspections were conducted.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Final design notice of the patient specific product was approved by the surgeon.A definitive root cause cannot be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 report: 0001825034-2017-09751.

Event Description

It was reported that the patient underwent initial surgery with a comprehensive vrs shoulder system.During the procedure, as the doctor drilled and secured the peripheral screw holes, he was unable to implant the central screw, either due to the drilled hole or the glenoid component itself.The surgeon also tried a second time, without success.Ultimately, the component was implanted without the central screw.It was further reported that the central guide does not fit well inside the central hole of the custom glenoid, furthermore the guide that comes with the glenoid is situated on the wrong side making use difficult because of exposure within the shoulder, thus contributing to this issue.Attempts have been made to obtain additional information however further information is not available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported products were reviewed for compatibility with no issues noted.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

No further event information available at the time of this report.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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: COMPREHENSIVE VRS GLENOID W/FAST GUIDES
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 6663924
• MDR Text Key: 78292084
• Report Number: 0001825034-2017-04218
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK152754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/18/2022

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 Expiration Date: 10/27/2017
• Device Model Number: N/A
• Device Catalogue Number: 110027734
• Device Lot Number: 872890
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 10/28/2017; 04/13/2020; 08/10/2022
• Supplement Dates FDA Received: 11/01/2017; 05/05/2020; 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 93 KG