MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item #: unknown, unknown humeral stem lot #: unknown; item #: unknown, unknown humeral bearing lot #: unknown; item #: unknown, unknown glenosphere lot #: unknown; item #: unknown, unknown glenoid baseplate lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02087, 0001825034 - 2021 - 02089, 0001825034 - 2021 - 02090, 0001825034 - 2021 - 02091.

Event Description

It was reported by pmi that a patient underwent an initial left shoulder arthroplasty on an unknown date.The patient is being considered for a pmi product on an unknown date for an unknown reason.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies 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 report 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

It was reported that the patient underwent a partial shoulder replacement on an unknown date.The surgeon wants to revise the construct to a reverse shoulder replacement for an unknown reason.

Manufacturer Narrative

(b)(4).D10: versa dial head: 113053, lot: 478620.Comp primary stem 9mm micro 113609 lot unknown.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/COMP TI STD TAPER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12165419
• MDR Text Key: 261438585
• Report Number: 0001825034-2021-02088
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060716
• 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
• Report Date: 11/09/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 963390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 08/10/2021; 11/03/2021
• Supplement Dates FDA Received: 08/11/2021; 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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