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

Catalog Number	115330
Medical Device Problem Codes	Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Dislocation (2374)
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: 115313 lot: j7817476 item name: comp rvsr shldr glnsp +3 36mm.Item: 405800 lot: 65757006 item name: comp.Rev shldr 9 in steinmann.Item: 118001 lot: j7569386 item name: versa-dial/comp ti std taper.Item: 115370 lot: 66917424 item name: comp rvs tray co 44mm.Item: 113648 lot: 66226600 item name: comp primary stem 8mm std.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.Imaging taken after the surgery showed loosening and dislocation of the glenosphere.Subsequently, the patient was revised 5 (five) days later; the glenosphere and taper adapter were removed and replaced.Due diligence is complete.No additional information is available.
Event or Problem Description
No additional information is available regarding the incident.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, g1, g3, g6, h2, h6, h11.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
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.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.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.

• 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: 21961151
• Report Number: 0001825034-2025-01319
• Device Sequence Number: 17960261
• Product Code: PHX
• UDI-Device Identifier: 00880304475342
• UDI-Public: (01)00880304475342(17)340415(10)66350698
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K193373
• 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
• 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 Catalogue Number: 115330
• Device Lot Number: 66350698
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 06/04/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/03/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male