MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP AUG MINI BSPLT W TPR SM; SHOULDER, PROSTHESIS

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 08/26/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source foreign: (b)(6).Concomitant medical products: comp rvrs shldr glnsp std 36mm cat: 115310 lot: j7094432.Unknown screw (x5).Unknown liner.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

It was reported that the patient underwent a revision procedure approximately eight months post implantation due to disassociation of the glenosphere from the baseplate.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

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.Visual examination of the provided pictures identified explanted product with signs of use and wear.However, as the products were not returned, further analysis could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: significant findings include reverse total shoulder arthroplasty of the right shoulder with disassociation of the glenosphere from the glenoid plate component and dislocation from the humeral component on the (b)(6) 2022 study.Device history record 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP AUG MINI BSPLT W TPR SM
• 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: 15494931
• MDR Text Key: 300701888
• Report Number: 0001825034-2022-02220
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304993235
• UDI-Public: (01)00880304993235(17)260218(10)64992921
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172502
• 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: 10/12/2022

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 Model Number: N/A
• Device Catalogue Number: 110032410
• Device Lot Number: 64992921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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.
• Patient Outcome(s): Hospitalization; Required Intervention