MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS SM FEM STEM 10 X 102MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6485-3-000
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Patient complained of leg pain.Xray showed bent or broken femur stem.Revision surgery performed with new stem.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a mrs stem was reported.The event was confirmed via clinician review of the provided medical records.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 information by a clinical consultant indicated: "this inquiry reports the failure of a distal femoral replacement implant less than one month postoperative due to a periprosthetic fracture with deformity of the proximal femoral stem.I can confirm that this event took place since i was able to view the x-rays of the fracture and the bent stem.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of periprosthetic fracture are multifactorial including surgical technique factors, trauma, and patient factors.Causes of a deformed or bent stem are also multifactorial including surgical technique factors, failure of adequate fixation, trauma, and implant factors." -product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to periprosthetic fracture of the femur.A review of the provided medical information by a clinical consultant indicated: "this inquiry reports the failure of a distal femoral replacement implant less than one month postoperative due to a periprosthetic fracture with deformity of the proximal femoral stem.I can confirm that this event took place since i was able to view the x-rays of the fracture and the bent stem.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of periprosthetic fracture are multifactorial including surgical technique factors, trauma, and patient factors.Causes of a deformed or bent stem are also multifactorial including surgical technique factors, failure of adequate fixation, trauma, and implant factors." 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, additional pre- and post-operative x-rays and the primary/revision operative reports as well as patient history and follow-up notes 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
Patient complained of leg pain.Xray showed bent or broken femur stem.Revision surgery performed with new stem.

• Brand Name: MRS SM FEM STEM 10 X 102MM
• 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: 13844968
• Report Number: 0002249697-2022-00418
• Device Sequence Number: 4013453
• Product Code: KRO
• UDI-Device Identifier: 07613327048278
• UDI-Public: 07613327048278
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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: 06/30/2024
• Device Model Number: 6485-3-000
• Device Catalogue Number: 64853000
• Device Lot Number: 204534C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 88 KG