MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CONVERTIBLE GLENOID BASEPLATE; SHOULDER, PROTHESIS

Catalog Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 07/26/2023

Event Type  Injury  

Event Description

It was reported that the patient was revised due to bearing disassociation approximately six months post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2023 -02267, 0001825034-2023-02012.D10: comp conv glen liner vivacit-e; cat: 110035767; lot: 65163943; mini tray std cocr +0 offset; cat: 110031399; lot: 65949545; versa-dial/comp ti std taper; cat: 118001; lot: 808600; comp rvrs shldr glnsp std 36mm; cat: 115310; lot: j7505348; hmrl bearing 36 mm std vite; cat: 110031424; lot: 65761078; versa-dial 46x18x53 hum head; cat: 113042; lot: j7298805; versa-dial/comp ti std taper; cat: 118001; lot: j7379786.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided for the unknown baseplate; visual and dimensional evaluations could not be performed.Medical records for the initial surgery were provided and reviewed by a health care professional.Review of the available records identified the following: rotator cuff intact.Glenoid convertible baseplate.Anatomic total shoulder performed without complications.Intraop imaging show good alignment of components.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The reported event is not confirmed; the revision is confirmed as pictures were provided and product returned, however the occurrence of disassociation cannot be confirmed.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: UNKNOWN CONVERTIBLE GLENOID BASEPLATE
• Type of Device: SHOULDER, PROTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18245463
• MDR Text Key: 329440459
• Report Number: 0001825034-2023-02819
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 56 KG