MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS HUMERAL STEM 7X 75MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	64875075
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646); 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.
Additional Manufacturer Narrative
Reported event: an event regarding loosening and periprosthetic fracture involving a mrs stem was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device is still implanted.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
No new information.

• Brand Name: MRS HUMERAL STEM 7X 75MM
• 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: 23334763
• Report Number: 0002249697-2025-01138
• Device Sequence Number: 18784709
• Product Code: HSD
• UDI-Device Identifier: 07613327049718
• UDI-Public: 07613327049718
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K040128
• 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,Followup
• Report Date (Section B): 12/19/2025

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: 10/31/2019
• Device Catalogue Number: 64875075
• Device Lot Number: 132449C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2014
• 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: Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female