MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 40MM HUMERAL BDY M/F TAPER; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	64871040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: as per pss implant request: loosening gmrs proximal humerus prosthesis with pathological fracture.History of periosteal chondrosarcoma proximal humerus, excision and replacement with gmrs proximal humerus done in 2015, defaulted follow up, came back with loosening with periprosthetic fracture, biopsy revealed no evidence of tumour recurrence.Plan for revision.

• Brand Name: MRS 40MM HUMERAL BDY M/F TAPER
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23360550
• Report Number: 0002249697-2025-01160
• Device Sequence Number: 9201927
• Product Code: HSD
• UDI-Device Identifier: 07613327048940
• UDI-Public: 07613327048940
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K954559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: 09/30/2015
• Device Catalogue Number: 64871040
• Device Lot Number: MAR793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female