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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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ARTHREX, INC. 24MM BASEPLATE, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Model Number 24MM BASEPLATE, MODULAR
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 02/26/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported through the surgical outcome system that a revision surgery is required due to the loosening of an arthrex prosthetic joint.The primary surgery took place on (b)(6) 2020.The complication was reported on (b)(6) 2020; indicating loosening of prosthetic joint and a revision required.The revision surgery took place on (b)(6) 2021.The following arthrex product was explanted during the revision surgery; ar-9560-24 (lot: 5655).Ar-9561-20p (lot: 7038).Ar-9562-36nl (lot: 2018005757).Ar-9562-40nl (lot: 2018001457).Ar-9563-20 (lot: 2019003063).Ar-9564-2436-lat (lot: 19.03388).Ar-9502f-36rcpc (lot: 19.00394).Ar-9503s-06 (lot: 170052510).The following arthrex product was implanted during the revision surgery; ar-9502f-36rcpc (lot: 20.01053).Ar-9555-06 (lot: 170143213).Ar-9503s-06 (lot: 20.01369).
 
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Brand Name
24MM BASEPLATE, MODULAR
Common Device Name
SHOULDER PROSTHESIS, REVERSE CONFIGURATION
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11485611
Report Number1220246-2021-02754
Device Sequence Number3913056
Product Code PHX
UDI-Device Identifier00888867296411
UDI-Public00888867296411
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K173900
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 03/15/2021
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 Number24MM BASEPLATE, MODULAR
Device Catalogue NumberAR-9560-24
Device Lot Number5655
Was Device Available for Evaluation? No
Distributor Facility Aware Date02/28/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/28/2021
Initial Report FDA Received Date03/15/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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