MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X35MM ST/RST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	115397
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: australia.D10 narrative: item:ep-010000589.Lot: 675430.Item number: comp rvrs 25mm bsplt ha+adptr.Item:ep-115395.Lot: 093300.Item number: e1 44-36 rtnv +3 hmrl brg.Item:115310.Lot: 045290.Item number: comp rvrs shldr glnsp std 36mm.Item:115370.Lot: 795950.Item number: comp rvs tray co 44mm.Item:113629.Lot: 491120.Item number: comp primary stem.9mm mini.Item:180553.Lot: 420680.Item number: comp lk scr 3.5hex.4.75x30 st.Item: 180553.Lot: 420680.Item number: comp lk scr 3.5hex.4.75x30 st.Item:180554.Lot: 330090.Item number: comp lk scr 3.5hex 4.75x35 st.Item:180554.Lot: 146450.Item number: comp lk scr 3.5hex 4.75x35 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 a patient had an initial right reverse total shoulder arthroplasty performed, which was revised 4 days later due to dissociation.Subsequently, the patient is now being considered for a patient matched implant due to unknown reasons.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.If any further information is found that 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.
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.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11 h10: related report #'s: 0001825034-2025-00722, 0001825034-2025-00724, 0001825034-2025-00723, 0001825034-2025-00726, 0001825034-2025-00727, 0001825034-2025-00728, 0001825034-2025-00730, 0001825034-2025-00729, 0001825034-2025-00731, and 0001825034-2025-00995.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.Nursing timeline reviewed information provided and identified the following: pmi request received, pending revision due to unknown reason.The rep response states that the patient was booked for a revision approximately 2 years ago (unknown if this is referring to knee or shoulder prosthesis).Medical records were not provided.A definitive root cause cannot be determined.Both baseplates/taper adapters are a part of a bet recall.The reason for this revision is unknown, and therefore, cannot be determined if the reported event is related to the deviations/recall.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 RVS CNTRL 6.5X35MM ST/RST
• 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: 21612481
• Report Number: 0001825034-2025-00725
• Device Sequence Number: 7625463
• Product Code: PHX
• UDI-Device Identifier: 00880304677098
• UDI-Public: (01)00880304677098(17)250617(10)478340
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 07/28/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2025
• Device Catalogue Number: 115397
• Device Lot Number: 478340
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 03/07/2025; 07/11/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/04/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2015
• 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 H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female