MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS HUMERAL STEM 9MM X 75MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	64873075
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following is reported in pss case: revision due to loosening of the stem.Revision to stryker mrs distal humerus system.Implant: mrs cementless stem with extra-cortical plate.Left side.Planned surgery date (b)(6) 2025.
Additional Manufacturer Narrative
The following devices were also listed in this report: 100mm standard ulna component, left; cat # 5005-u-100l; lot # erjn07917e.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a mrs humeral stem was reported.The event was confirmed via clinician review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: confirmation of event: i can confirm that the patient underwent implantation of a tumor type elbow prosthesis since i was able to view images with the implant place.The radiographic findings are consistent with loosening.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of loosening of a tumor type prothesis approximately two years following implantation are multi factorial including surgical technique in the way the implant is positioned and the method of fixation, as well as host bone factors including recurrence of tumor.Patient factors include activity level and lifestyle.With the information provided i would not assign any causality to the implant itself.-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.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following is reported in pss case: revision due to loosening of the stem.Revision to stryker mrs distal humerus system.Implant: mrs cementless stem with extra-cortical plate.Left side.Planned surgery date (b)(6) 2025.Update: osteosarcoma is not the cause for loosening of stem.Patient has been in pain more than 6 months.We found that loosening of the stem is the most likely reason, no tumor recurrence found.No infection noted.

• Brand Name: MRS HUMERAL STEM 9MM X 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: 23059578
• Report Number: 0002249697-2025-00983
• Device Sequence Number: 9671896
• Product Code: HSD
• UDI-Device Identifier: 07613327049046
• UDI-Public: 07613327049046
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K954559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 10/31/2025
• Device Catalogue Number: 64873075
• Device Lot Number: 178238B
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2020
• 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: 16 YR
• Patient Sex: Female
• Patient Weight: 71 KG