MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X25MM ST/RST; SHOULDER PROSTHESIS SCREW

Catalog Number	115395
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Procode: phx.Comp aug mini bsplt w tpr lg cat# 110032430 lot# 64228644.Comp lk scr 3.5hex 4.75x30 st cat# 180553 lot# 420090.Comp lk scr 3.5hex 4.75x30 st cat# 180553 lot# 498970.Comp lk scr 3.5hex 4.75x15 st cat# 180550 lot# 234020.Unknown locking screw cat#ni lot#ni.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: 0001825034-2022-00538, 0001825034-2022-00540, 0001825034-2022-00541, 0001825034-2022-00542, 0001825034-2022-00543.
Event or Problem Description
It was reported that a patient is being considering for a revision at an unknown date due to total failure of the glenoid components (broken screws and baseplate pulled out from glenoid).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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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: fractured glenosphere screws with loosening of the glenoid component.Possibly related to extensive glenoid heterotopic ossification.Radiolucency surrounding the glenosphere, consistent with loosening.Bony impaction of the humeral component with the heterotopic ossification arising of the inferior aspect of the glenoid.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
No further event information is available at the time of this report.

• Brand Name: COMP RVS CNTRL 6.5X25MM 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: 13758021
• Report Number: 0001825034-2022-00539
• Device Sequence Number: 5826246
• Product Code: PHX
• UDI-Device Identifier: 00880304677074
• UDI-Public: (01)00880304677074(17)301008(10)071970
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 04/26/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 115395
• Device Lot Number: 071970
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male