MAUDE Adverse Event Report: ARTHREX, INC. REVERS 39MM CA ADAPTER ASSEMBLY; KNEE PROSTHESIS

Model Number	REVERS 39MM CA ADAPTER ASSEMBLY
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/28/2025, a sales representative reported via email that two ar-9502-39arca univers revers ca humeral head adapter 39 components could not be secured during surgery.The procedure was a revision reverse shoulder arthroplasty on (b)(6) 2025.During the operation, the original liner was removed from the patient.When attempting to place both ar-9502-39arca univers revers ca humeral head adapter 39 into the 39 suture cup, neither adapter would snap into place.Additional information has been requested if a revision surgery was due to an issue with an arthrex product on (b)(6) 2025.
Event or Problem Description
Additional information was received on 11/03/2025: the patient underwent a revision reverse shoulder arthroplasty on (b)(6) 2025 following a fall-related incident.During the procedure, attempts to implant two components, ar-9502-39arca univers revers ca humeral head adapter 39 and ar-9556-22rca univers revers ca humeral head 56/22, were unsuccessful as they could not be secured.This issue extended the surgical time by approximately 30 minutes.As part of the revision, all implants from the original reverse shoulder arthroplasty performed in (b)(6) 2023 were explanted.The original surgery was performed at the same facility by the same surgeon and had no reported intraoperative complications.The arthrex products implanted in the original surgery include, ar-9503m-03 arthrex univers revers humeral insert medium / 39 / +3, ar-9502f-39cpc arthrex univers revers suture cup, 39 (neutral), ar-9562-28nl univers revers modular glenoid system, peripheral screw, non-locking 4.5 x 28 mm, ar-9563-20 univers revers modular glenoid system, peripheral screw, locking 5.5 x 20 mm, ar-9563-28 univers revers modular glenoid system, peripheral screw, locking 5.5 x 28 mm, ar-9564-2439-lat arthrex univers revers modular glenoid system glenosphere 39 +4 lat / 24, ar-9501-12s univers revers apex humeral stem size 12, ar-9580-2410-2 univers revers modular glenoid system, augmented baseplate 24 mm +2, 10° full.The arthrex products that were implanted in the revision surgery were two ar-901-mvg arthrex bone cement mv /g (lot: ar02400010), ar-901-hvg arthrex bone cement hv w/g (lot: ar02400017), and an ar-902-1248m cemend shoulder spacer mold 12-48 (ar02500018).The patient's current health status was reported as good.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is user error, including incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.Univers revers shoulder system surgical technique guides - humeral preparation surgical technique preoperative planning preoperative planning may have a significant impact on the surgical outcome, especially if it is overlooked.Quality shoulder radiographs should include true a/p, axillary lateral, and supraspinatus outlet views.Technicians should use a reproducible process that generates images with consistent and predictable magnification for templating.The univers revers total shoulder system includes a set of templating transparencies for glenoid and humeral component sizing.Additional radiographic studies, such as ct and mri to evaluate glenoid geometry and soft-tissue quality, respectively, complement a thorough diagnostic workup.With a ct study, the virtual implant positioning (vip) system can be used to accurately plan and execute glenoid component implantation.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: REVERS 39MM CA ADAPTER ASSEMBLY
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23477353
• Report Number: 1220246-2025-05013
• Device Sequence Number: 10526561
• Product Code: HSD
• UDI-Device Identifier: 00888867230385
• UDI-Public: (01)00888867230385(11)211001(17)260930(10)19.02987
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K151527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: REVERS 39MM CA ADAPTER ASSEMBLY
• Device Catalogue Number: AR-9502-39ARCA
• Device Lot Number: 19.02987
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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
• Patient Sex: Unknown