MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE CENTRIC 40 MM DIAMETER +0 MM LATERAL OFFSET; SHOULDER, PROSTHESIS

Catalog Number 00436004000

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4), proposed g-code: mechanical (g04) - head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2023 -01349.D10: base plate uncemented 25 mm post length cat: 00436202500, lot: 64610507 40mm vit e liner +0mm, cat: 00435004000, lot: 65226145.Visual examination of the returned product identified damage near the threaded hole, however, visual examination of the inner features found no damage.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no definite acute abnormality detected with respect of the glenosphere.No signs of loosening, wear, radiolucency or other contributing factors, and there is no cause for the glenosphere to be not tapered to the baseplate.Overall fit and alignment of the implants as well as bone quality appears grossly unremarkable.Hardware appears intact without periprosthetic lucencies.Bones appear intact.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.The reported event is not confirmed.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 the patient was revised due to baseplate disassociation, liner wear and pain.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: GLENOSPHERE CENTRIC 40 MM DIAMETER +0 MM LATERAL OFFSET
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17797205
• MDR Text Key: 324004954
• Report Number: 0001822565-2023-02618
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172767
• 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
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00436004000
• Device Lot Number: 65718018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 99 KG