MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM VERSA-DIAL TAPER ADAPTOR; SHOULDER, PROSTHESIS

Model Number	118000
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Joint Dislocation (2374)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Bearing +3 mm retentive thickness 36 mm diameter cat: 110031426 lot: 64465284.Comp lk scr 3.5hex 4.75x30 st cat: 180553 lot: 791810.Comp rvrs shldr glnsp std 36mm cat: 115310 lot: 662660.Comp rvrs 25mm bsplt ha+adptr cat: 010000589 lot: 564600.Comp rvs cntrl 6.5x30mm st/rst cat: 115396 lot: 100840.Comp lk scr 3.5hex 4.75x25 st cat: 180552 lot: 792150.Comp primary stem 9mm mini cat: 113629 lot: 170250.Bearing standard 36 mm diameter cat: 110031424 lot: 64510457.Mini tray std cocr +3 offset cat: 110031402 lot: 64512179.Comp rvrs 25mm bsplt ha+adptr cat: 010000589 lot: 564600.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01534, 0001825034-2023-01301.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 the patient fell and the glenosphere was dislocated.The bearing was found to be worn.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
It was reported that a patient fell causing disassociation between the taper adapter and the baseplate.After the fall and before the revision occurred, the baseplate was wearing on the poly which caused an abnormal wear pattern.The baseplate wore down to the humeral tray leading to metal on metal wear.Debris of the metal on metal wear is present on the poly.The complications were indicated as being the result of the fall with no concerns or allegations prior.As this is an upper extremity implant, it would not have caused/contributed to the fall and subsequent complications.This complaint will be considered not reportable as the device is not related to the event.This subform will be voided as the taper adapter is captured under medwatch 0001825034-2023-01301, 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: 25MM VERSA-DIAL TAPER ADAPTOR
• Common Device Name: 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: 17108216
• Report Number: 0001825034-2023-01300
• Device Sequence Number: 6243896
• Product Code: KWS
• UDI-Device Identifier: 00880304531048
• UDI-Public: (01)00880304531048(17)291103(10)741600
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K202232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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 Model Number: 118000
• Device Catalogue Number: 118000
• Device Lot Number: 741600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Female