MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	115400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial rsa using a vrs on approximately two (2) years and two (2) months ago.Subsequently, the patient came into the hospital on an unknown date approximately one (1) year and nine (9) months post-implantation complaining of pain in the affected area.An x-ray revealed that the lower screw of the baseplate had fractured.At the time, it did not appear that there was looseness in the baseplate, and no bone fracture site has been identified.The patient later underwent a revision surgery approximately two (2) years post-implantation where the vrs glenoid component was noted to not be integrated with the bone and was floating.All fractured screws were removed using a removal kit.The stem remained stable, so the stem, tray, and liner were left in place.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# 110027734; lot# 66344568 item# 180553; lot# 65965000 item# 180553; lot# 65965003 item# 180554; lot# 66138796 g2: foreign - event occurred in japan customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual examination of the returned screws identified all four have fractured.Fracture analysis performed on lots 5965000, 65965003, & 66138796 identified the screw fracture surfaces exhibited ratchet marks and beach marks artifacts, suggesting that they were possibly fractured due to fatigue mode of failure.The fracture surface on the screw with lot 409840 appeared to be severely damaged with no fracture artifacts to evaluate, and thus the failure mode for the screw couldn't be determined.Review of the vrs baseplate identified signs of use and damage to the screw holes and porous coating.Medical records were not provided.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 event was confirmed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a1; b4; b5; d2; g1; g3; g6; h1; h2.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent an initial rsa using a vrs on approximately two (2) years and two (2) months ago.Subsequently, the patient came into the hospital on an unknown date approximately one (1) year and nine (9) months post-implantation complaining of pain in the affected area.An x-ray revealed that the lower screw of the baseplate had fractured.At the time, it did not appear that there was looseness in the baseplate, and no bone fracture site has been identified.The patient later underwent a revision surgery approximately two (2) years post-implantation where the vrs glenoid component was noted to not be integrated with the bone and was floating.All fractured screws were removed using a removal kit.The stem remained stable, so the stem, tray, and liner were left in place.Attempts have been made and no further information has been provided.The patient is now being considered for a custom implant.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW
• 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: 24137333
• Report Number: 0001825034-2026-00180
• Device Sequence Number: 5430573
• Product Code: PHX
• UDI-Device Identifier: 00880304677128
• UDI-Public: (01)00880304677128(17)320210(10)409840
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 04/07/2026

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: Lay User/Patient
• Device Catalogue Number: 115400
• Device Lot Number: 409840
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/18/2026; 03/24/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/19/2026; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male