MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHDR GLEN BSPLT +HA; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 115330

Device Problem Failure to Osseointegrate (1863)

Patient Problem Erosion (1750)

Event Date 08/23/2022

Event Type  Injury  

Event Description

It was reported that patient was revised approximately one (1) year and two (2) months post-implantation due to no fixation of the baseplate and two (2) fractured screws.During the procedure, the baseplate, glenosphere, poly and screws were removed and patient was converted to a hemi shoulder.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02127, 0001825034-2022-02128.Device product code - phx.Concomitant medical products: item# 115396; lot# 905900.Item# 180552; lot# 763020.Item# 180552; lot# 905490.Item# 110030777; lot#11024237.Item#110031400; lot# 65095786.Item# 110031421; lot# 64343831.Item#118001; lot# j7192948.Item#113077; lot# 314170.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 visual examination of the provided photographs identified the implants that were explanted.A central screw and peripheral screw appear broken.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: significant findings include a fractured central screw of the glenoid component is identified.No contribute factors are seen.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP RVRS SHDR GLEN BSPLT +HA
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 15445749
• MDR Text Key: 300138367
• Report Number: 0001825034-2022-02126
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304475342
• UDI-Public: (01)00880304475342(17)310204(10)185040
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193373
• 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: 01/12/2023

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: 115330
• Device Lot Number: 185040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 143 KG