MAUDE Adverse Event Report: ARTHREX, INC. REVERS CA HUMERAL HEAD, 56/22; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	REVERS CA HUMERAL HEAD, 56/22
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, a sales representative reported via email that the following arthrex parts (qty.2) of an ar-9502-42arca univers revers ca humeral head adapter 42, ar-9502-39arca univers revers ca humeral head adapter 39, ar-9556-22rca univers revers ca humeral head 56/22, ar-9502f-42cpc arthrex univers revers suture cup, 42, ar-9502f-39cpc arthrex univers revers suture cup, 39 (neutral), ar-9501-10p arthrex univers revers humeral stem, size 10 were unsuccessful in seating the 42 adapter into the 42 cup.A 39 adapter and a 39 cup were also attempted but unsuccessful in properly seating.Nothing broke inside the patient.The procedure was aborted.This was discovered during a revision reverse shoulder procedure on (b)(6) 2025.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 02/26/2025: another surgery has been rescheduled due to the case being fully aborted.No piece of the implants or driver mechanisms broke.It is unknown if there was a case delay during this procedure or if added anesthesia was administered to the patient.No adverse effects or significant damage on or after the surgery were reported.This occurred in a revision rtsa to reverse ca head and adapter procedure on (b)(6) 2025.Additional information was received on 03/11/2025: the initial revision case was for a tsa to rtsa.There was no information on the onset of the patient's issue/symptoms.All opened and extracted parts were stated in the initial complaint and returned.
Event or Problem Description
Additional information was received on 03/11/2025: the initial revision case was for a tsa to rtsa.There was no information on the onset of the patient's issue/symptoms.All opened and extracted parts were stated in the initial complaint and returned.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.It was concluded that there is no allegation against the ar-9556-22rca, serial/batch number (b)(6).One unpackaged ar-9556-22rca, serial/batch number (b)(6), was received for investigation.Visual inspection revealed scratches on the polished surface.No major issues were noted.Functional testing was performed by inserting the returned ar-9502-42arca and ar-9502-39arca.No problem was found.It was concluded that there is no allegation against the ar-9556-22rca, serial/batch number (b)(6).Not related to the allegation problem found.

• Brand Name: REVERS CA HUMERAL HEAD, 56/22
• Common Device Name: SHOULDR PROSTH HEMI- HUM UNCEM
• 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: 21536289
• Report Number: 1220246-2025-00800
• Device Sequence Number: 12546122
• Product Code: HSD
• UDI-Device Identifier: 00888867229594
• UDI-Public: (01)00888867229594(11)240820(17)290731(10)15305003
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 07/07/2025

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 Model Number: REVERS CA HUMERAL HEAD, 56/22
• Device Catalogue Number: AR-9556-22RCA
• Device Lot Number: 15305003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: Not provided; 06/10/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/14/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown