MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SM HYBRID GLENOID BASE 4MM; SHOULDER, PROSTHESIS

Catalog Number 113952

Device Problem Fracture (1260)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 11/22/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2023 -03007.D10: pt hybrid glen post regenerex cat: pt-113950 lot: 187380.G2: foreign: australia.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.

Event Description

It was reported patient was revised due to rotator cuff failure and implant fracture approximately eight months post operation.The glenoid post and poly were exchanged.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product/provided pictures identified signs of use with some debris around the threads of the glenoid base as well as some scratches, gouges, and debris embedded into the working surface of the glenoid base.The threaded posts also have damage near the top of the threads.The regenerex post is fractured and not all of the post was returned.Fracture analysis could not be performed as the fracture is too smeared.Device history record was reviewed and no discrepancies were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views of the right shoulder demonstrate a shoulder arthroplasty with radiolucent glenoid component and what appears to be a fractured central peg.Humeral component is intact with radiolucency along the baseplate.Superior subluxation of the humeral head is noted on the second image.No problem was found with the product so the event is unconfirmed.The glenoid was found not to be related to the rotator cuff injury.This medwatch will be considered not reportable.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

It was reported patient underwent a revision procedure approximately 21 months post implantation due to rotator cuff failure and glenoid post implant fracture.The humeral and glenoid components were removed and exchanged without complication.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: versa-dial 42x18x46 hum head cat: 113032 lot: 293080.Compr nano hmrl pps 30mm cat: 115730 lot: 271400.Versa-dial/comp ti std taper cat: 118001 lot: 386740.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: SM HYBRID GLENOID BASE 4MM
• Type of Device: SHOULDER, PROSTHESIS
• 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: 18348202
• MDR Text Key: 330771159
• Report Number: 0001825034-2023-03008
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 0088304462625
• UDI-Public: (01)0088304462625(17)260909(10)346830
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113952
• Device Lot Number: 346830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• 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.; SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 65 KG