MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Dislocation (2374); Aseptic loosening (4883)
Date of Event	11/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under: (b)(4).G2, country event occurred in: poland.D10 narrative: item: xl-115363, lot: 66831643, item name: arcom xl 44-36 std hmrl brng, d10 narrative: item: 118001, lot: j7569386, item name: versa-dial/comp ti std taper, item: 405800, lot: 65757006 , item name: comp.Rev shldr 9 in steinmann, item: 115370, lot: 66917424, item name: comp rvs tray co 44mm, item: 113648, lot: 66226600, item name: comp primary stem 8mm std, item: 115330, lot: 66350698, item name: comp rvrs shdr glen bsplt +ha, item: 115395, lot: 66494759, item name: comp rvs cntrl 6.5x25mm st/rst, item: 180550, lot: 66579653, item name: comp lk scr 3.5hex 4.75x15 st, item: 180551, lot: 66602907, item name: comp lk scr 3.5hex 4.75x20 st, item: 180551, lot: 66783776, item name: comp lk scr 3.5hex 4.75x20 st.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that the patient was implanted with a shoulder system.Subsequently, the patient was revised due to dislocation.There was harm or injury to patient as the patient had to undergo additional surgical procedure.Due diligence is complete.No additional information is available.
Event or Problem Description
It was reported that the patient was implanted with a shoulder system.Subsequently, the patient was revised due to dislocation and loosening of the glenosphere.There was harm or injury to patient as the patient had to undergo additional surgical procedure.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: poland.D10 narrative: item: xl-115363.Lot: 66831643.Item name: arcom xl 44-36 std hmrl brng.Item: 405800.Lot: 65757006.Item name: comp.Rev shldr 9 in steinmann.Item: 115370.Lot: 66917424.Item name: comp rvs tray co 44mm.Item: 113648.Lot: 66226600.Item name: comp primary stem 8mm std.Item: 115330.Lot: 66350698.Item name: comp rvrs shdr glen bsplt +ha.Item: 115395.Lot: 66494759.Item name: comp rvs cntrl 6.5x25mm st/rst.Item: 180550.Lot: 66579653.Item name: comp lk scr 3.5hex 4.75x15 st.Item: 180551.Lot: 66602907.Item name: comp lk scr 3.5hex 4.75x20 st.Item: 180551.Lot: 66783776.Item name: comp lk scr 3.5hex 4.75x20 st.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that the taper has scratches on the surface and the post as well.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event is not confirmed.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: VERSA-DIAL/COMP TI STD TAPER
• 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: 21047293
• Report Number: 0001825034-2024-03093
• Device Sequence Number: 11583032
• Product Code: PHX
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249(17)330711(10)J7569386
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2025

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: N/A
• Device Catalogue Number: 118001
• Device Lot Number: J7569386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 05/13/2025; 06/04/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 06/03/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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 H11 NARRATIVE; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male