MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROXIMAL TIBIAL STANDARD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6495-3-102
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
A patient specific prescription form has been received "proximal tibial replacement - loosening with significant tibial stress reaction - for giant cell tumour" update (b)(6) 2022 : as reported via updated implant request form: "revision of a gmrs proximal tibia.This will be the 3rd revision.Need a distal end piece that will connect to the mrh section of the femur.".
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a gmrs tibial component was reported.The event was confirmed based on medical review.Method & results: device 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: the x-rays show a gmrs tka with proximally replacing tibial and distal femoral replacing hinge components with cemented stem.There are subtle lucencies around the stem indicating possible early loosening.In addition, there are calcifications at the tip of the stem consistent with stress reaction.The clinic note states that the patient had initially done quite well but 2 months prior to the visit to the clinic had gone an extensive walk and subsequently developed unrelenting significant startup pain limiting her activities.Revision surgery for tibial loosening as a result of recurrent giant cell tumor in the proximal tibia is confirmed as is anterior tibial pain.There are radiographic findings consistent with stress reaction of about the tip of the cemented tibial stem as well as lucencies suggestive of possible early loosening.The root cause of this pain and possible mechanical failure cannot be determined from this limited documentation.Should additional information become available i would be happy to further this assessment." device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the patient was revised due to loosening.The event was confirmed based on medical review.No further investigation for this event is required.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
A patient specific prescription form has been received "proximal tibial replacement - loosening with significant tibial stress reaction - for giant cell tumour." update 22/august/2022 : as reported via updated implant request form: "revision of a gmrs proximal tibia.This will be the 3rd revision.Need a distal end piece that will connect to the mrh section of the femur." update as per office note on 8/11/2022: patient developed constant pain down anterior distal shin.X-rays showed continued stress reaction around the distal tibial stem.

• Brand Name: GMRS PROXIMAL TIBIAL STANDARD
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15342534
• Report Number: 0002249697-2022-01289
• Device Sequence Number: 14682960
• Product Code: KRO
• UDI-Device Identifier: 07613327048865
• UDI-Public: 07613327048865
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2022

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: 12/31/2024
• Device Model Number: 6495-3-102
• Device Catalogue Number: 64953102
• Device Lot Number: 154760L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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: 45 YR
• Patient Sex: Female