MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM XS LFT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-1-100
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent primary left tka outside of cors scope.On (b)(6), 2019, patient was revised for mechanical issues.Patient presented again with pain and signs of femoral loosening.Was revised on (b)(6) 2022.All components were exchanged except tibial components.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a mrh femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, dimensional and functional inspections were not performed as no devices were returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: 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.Device not returned.
Event or Problem Description
Patient underwent primary left tka outside of cors scope.On (b)(6) 2019, patient was revised for mechanical issues.Patient presented again with pain and signs of femoral loosening.Was revised on (b)(6) 2022.All components were exchanged except tibial components.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a mrh femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis, visual, dimensional and functional inspections were not performed as no devices were returned.Clinician review: a review of medical records with a clinical consultant indicated" this patient underwent multiple surgeries following bilateral total knee arthroplasties.This inquiry concerns the left knee which had been revised elsewhere initially and then underwent two revisions, one for instability and one for femoral loosening.I can confirm that the patient underwent a revision procedure since the pre-revision radiographs show a revision implant in place with a dislocated patella.I can confirm that the patient underwent a third revision for femoral loosening since i was able to review the operation report and post revision x-rays.The causes of failure of a primary knee arthroplasty due to mechanical issues such as loosening, and instability such as extensor mechanism disruption, are multifactorial and the root cause of these failures cannot be determined with certainty.They could be attributed to surgical factors including cementing technique, positioning, alignment, restoration of kinematics and restoration of the extensor mechanism.Patient factors including activity level and bmi can also be causative.I would not assign any causality to the implants themselves." device history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the event was confirmed via evaluation of medical records by a clinical consultant.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MRH KNEE FEM XS LFT
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15986080
• Report Number: 0002249697-2022-01835
• Device Sequence Number: 17664739
• Product Code: KRO
• UDI-Device Identifier: 07613327045109
• UDI-Public: 07613327045109
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: 11/30/2023
• Device Model Number: 6481-1-100
• Device Catalogue Number: 64811100
• Device Lot Number: EHC2N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2018
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 88 KG