MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP SML R 65MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	64952020
Medical Device Problem Codes	Loss of Osseointegration (2408); Malposition of Device (2616)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: as per pss implant request: failure of right distal femoral replacement.Primary right tha in 2019 for osteoarthritis secondary to crowe iv dysplasia with competitor stem, with shortening osteotomy and lateral locking plate.Fall and right distal femur fracture in 2023.Treated with stryker gmrs distal femoral replacement, small size femur component with 10x102 stem cut short, small size 1 tibia component, 10mm insert, and lateral plate to bridge knee stem and hip stem.Noticed worsening distal femur deformity during rehab.Distal femoral component is loose.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding loosening and subsequent malposition involving a gmrs femoral component was reported.The event was confirmed via a review of the medical records by a clinician.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: 'i have reviewed the documentation provided including the product inquiry cover sheet, an operative note, ap, lateral tka x rays as well as ap and oblique x-rays of the right femur.' 'the operative report describes a complex comminuted peri-prosthetic fracture of a distal femur below a press fit tha.The x-rays demonstrate a stemmed distal femoral replacing tka along with a lateral fixation plate.The femur has gone on to varus angulation with loss of fixation of the dfr femur and plate.Varus mal-angulation with loss of fixation of the dfr femoral component and lateral plate is confirmed.The root cause for this mechanical complication cannot be determined from the limited documentation provided.' -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: a review of the provided medical records by a clinical consultant indicated: i have reviewed the documentation provided including the product inquiry cover sheet, an operative note, ap, lateral tka xrays as well as ap and oblique x-rays of the right femur.'the operative report describes a complex comminuted peri-prosthetic fracture of a distal femur below a press fit tha.The x-rays demonstrate a stemmed distal femoral replacing tka along with a lateral fixation plate.The femur has gone on to varus angulation with loss of fixation of the dfr femur and plate.Varus mal-angulation with loss of fixation of the dfr femoral component and lateral plate is confirmed.The root cause for this mechanical complication cannot be determined from the limited documentation provided.' the exact cause of the event could not be determined because insufficient information was provided.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: GMRS DIST FEM COMP SML R 65MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23334720
• Report Number: 0002249697-2025-01139
• Device Sequence Number: 10523978
• Product Code: JDI
• UDI-Device Identifier: 07613327048759
• UDI-Public: 07613327048759
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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 Catalogue Number: 64952020
• Device Lot Number: UNKNOWN
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 71 KG