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

Catalog Number 113952

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094)

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pt hybrid glen post regenerex cat# pt-113950 lot#482100.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 mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02019.

Event Description

It was reported that a patient underwent a revision procedure approximately 20 months post implantation after a sudden onset of pain and pop in the shoulder.  during the revision, the surgeon excised scar tissue, synovitis, and adverse tissue reaction.  the glenoid was floating free in the joint and fractured through the metal stem within the glenoid vault.  the glenoid post, glenoid, adapter, and head were revised.  the stem was retained.  attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: SM HYBRID GLENOID BASE 4MM
• Type of Device: PROSTHESIS, SHOULDER
• 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: 15335871
• MDR Text Key: 299063658
• Report Number: 0001825034-2022-02020
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304462625
• UDI-Public: (01)00880304462625(17)241009(10)952230
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

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: Health Professional
• Device Catalogue Number: 113952
• Device Lot Number: 952230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2019
• 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: Female