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

Catalog Number	115330
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: 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
• Report Number: 0001825034-2022-02126
• Device Sequence Number: 7529809
• Product Code: PHX
• UDI-Device Identifier: 00880304475342
• UDI-Public: (01)00880304475342(17)310204(10)185040
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 143 KG