MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X45MM ST/RST; SHOULDER PROSTHESIS SCREW

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 10 months postimplantation due to impingement of the humeral bearing and custom glenoid.Glenosphere and vrs were removed and the tray and bearing swapped with a versadial head.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Procode: phx.Concomitant products: compr vrs glen pps min tpr adr cat# 110027734 lot# 604210.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00990.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 10 months postimplantation due to impingement of the glenosphere and custom glenoid.Glenosphere and vrs were removed and the tray and bearing swapped with a versadial head.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g3, g6, h2, h6, h10 d10: compr vrs glen pps min tpr adr cat# 110027734 lot# m604210 unknown screw cat#ni lot#ni unknown screw cat#ni lot#ni unknown screw cat#ni lot#ni unknown screw cat#ni lot#ni h6: component code: proposed code: mechanical (g04) ¿ head visual examination of the provided pictures and videos identified the bearing is worn secondary to impinging on the bone.However, as the products were not returned further visual and dimensional analysis could not be performed.Pn 110027734: review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: multiple glenoid implant fixation screw fractures.Mild glenoid implant displacement.Suspected metal on metal implant contact.The humeral implant fit is maintained.There is apparent glenoid implant loosening and mild displacement secondary to multiple fractured fixation screws.Bone quality is osteopenic.There appears to be implant impingement.A definitive root cause cannot 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00990 0001825034 - 2022 - 01380 0001825034 - 2022 - 01381 0001825034 - 2022 - 01382 0001825034 - 2022 - 01383.
Additional Manufacturer Narrative
D2: (b)(4).D10: comp lk scr 3.5hex 4.75x45 st cat#180556 lot#568350.Comp lk scr 3.5hex 4.75x45 st cat#180556 lot#641340.Comp lk scr 3.5hex 4.75x35 st cat#180554 lot#618140.Comp lk scr 3.5hex 4.75x35 st cat#180554 lot#247540.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported event has not changed.A definitive root cause cannot 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.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 10 months post implantation due to impingement of the glenosphere and custom glenoid along with the fracturing of the screws.Glenosphere and vrs were removed along with all screws.The tray and bearing were swapped with a versadial head.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional/corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00990-3, 0001825034-2022-01380-3, 0001825034-2022-01381-3, 0001825034-2022-01382-3, 0001825034-2022-01383-3.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 RVS CNTRL 6.5X45MM ST/RST
• Common Device Name: SHOULDER PROSTHESIS SCREW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14239496
• Report Number: 0001825034-2022-00991
• Device Sequence Number: 11802073
• Product Code: PHX
• UDI-Device Identifier: 00880304677111
• UDI-Public: (01)00880304677111(17)251214(10)399550
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup,Followup,Followup
• Report Date (Section B): 07/26/2023

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 Expiration Date: 12/14/2025
• Device Model Number: N/A
• Device Catalogue Number: 115399
• Device Lot Number: 399550
• 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: 04/06/2022
• Supplement Date Received by Manufacturer: 05/19/2022; 06/02/2022; 09/06/2022; 10/07/2022; 06/28/2023
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/24/2022; 06/09/2022; 09/15/2022; 10/11/2022; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 FOR UPDATES.; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown