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

Model Number	6495-2-040
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Aseptic mobilization during a secondary implant for knee prosthesis revision.
Additional Manufacturer Narrative
An event regarding loosening involving a gmrs femoral component was reported.The event was confirmed based on medical review.Method & results: - device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs show scratch marks on the femoral component.Dimensional, functional and material analysis could not be performed as the device was not returned.- clinician review: a review of the provided medical records by a clinical consultant indicated: conclusion of assessment: this inquiry reports loosening of a gmrs implant which replaced a significant portion of the distal femur.It is unclear whether the x-ray dated (b)(6) 2021 is the preop or postop x-ray.Reviewing the photos again, i do not see a tibial baseplate with stem extension so the x-ray may have been postop.I can confirm that this event took place since i was able to review the x-rays and photographs and translation of the operation note.It would be helpful to have a translation of the question and answer portion as well.Regarding the possible root cause of this event, i cannot determine it with certainty.Loosening of a mega/tumor tape prosthesis that replaces a significant portion of distal bone is prone to loosening because of the stresses applied.Also key in longevity of these implants is proper fixation in terms of cement and length of stem.I see no defect or problem with the implant.Once an implant loosens and angular deformity occurs, it is not uncommon for polyethylene pieces to break or fragment.- 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.The exact cause of the event could not be determined because insufficient information was provided.Additional information including 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
Aseptic mobilization during a secondary implant for knee prosthesis revision.

• Brand Name: GMRS DIST FEM COMP STD R 65MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12065105
• Report Number: 0002249697-2021-01078
• Device Sequence Number: 3926582
• Product Code: KRO
• UDI-Device Identifier: 07613327048780
• UDI-Public: 07613327048780
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 09/02/2021
• Device Model Number: 6495-2-040
• Device Catalogue Number: 64952040
• Device Lot Number: A6A3D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention