MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH FEMORAL STYLUS; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6541-1-605
Medical Device Problem Codes	Incorrect Measurement (1383); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.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.Device not available.
Event or Problem Description
The surgeon reported that he was under taking a knee replacement procedure and that when he was using the femoral sizer, this resulted in notching the femur.Update: the surgeon reported that the stylus indicates smaller size than the level of the cut.
Event or Problem Description
The surgeon reported that he was under taking a knee replacement procedure and that when he was using the femoral sizer, this resulted in notching the femur **update** the surgeon reported that the stylus indicates smaller size than the level of the cut.
Additional Manufacturer Narrative
An event regarding other involving a triathlon guide was reported.The event was confirmed via product evaluation.Method & results -product evaluation and results: visual inspection of the returned device noted the following: device was returned in used condition.Notable signs of wear and discoloration throughout the device.Dimensional inspection of the returned device noted the following: according to the dimensional analysis, the device is out of specification.Inspection attached.The device¿s current condition would not be an accurate reflection of its original manufactured condition.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: this event, which represents a female patient, dob (b)(6) 1950 described as 163 cm tall and weighing 91 kg.The event description states: ".When using the femoral sizer, this resulted in notching the femur." undated x-rays: ap both knees, lateral left knee: osteoarthritic left knee undated x-rays: ap and lat left knee: cemented left tka with no patellar resurfacing, anterior femoral notch behind femoral component.Poorly legible handwritten operative note: left knee replacement mentions "notch of 5mm" implant labels: triathlon #4 left cr femur, #4 primary tibial baseplate, #4/11cr insert, palacos bone cement.No clinical or pmh, no clinical follow-up, no listing of surgical instruments used or description of their use.While the x-ray confirms the notching of the femur, insufficient information is presented to create a medical report regarding the relationship of the surgical instruments to the creation of the femoral notch in this case.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: dimensional inspection of the returned device noted the following: according to the dimensional analysis, the device is out of specification.However, the device¿s current condition would not be an accurate reflection of its original manufactured condition.A review of the provided medical records by a clinical consultant stated the following comment: re pi - 2464402 which represents a female patient, dob 2/7/50 described as 163 cm tall and weighing 91 kg.The event description states: ".When using the femoral sizer, this resulted in notching the femur." undated x-rays: ap both knees, lateral left knee: osteoarthritic left knee undated x-rays: ap and lat left knee: cemented left tka with no patellar resurfacing, anterior femoral notch behind femoral component.Poorly legible handwritten operative note: left knee replacement mentions "notch of 5mm" implant labels: triathlon #4 left cr femur, #4 primary tibial baseplate, #4/11cr insert, palacos bone cement.No clinical or pmh, no clinical follow-up, no listing of surgical instruments used or description of their use.While the x-ray confirms the notching of the femur, insufficient information is presented to create a medical report regarding the relationship of the surgical instruments to the creation of the femoral notch in this case.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: FEMORAL STYLUS
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10501777
• Report Number: 0002249697-2020-01806
• Device Sequence Number: 14123233
• Product Code: HRY
• UDI-Device Identifier: 07613327240894
• UDI-Public: 07613327240894
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K172326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2018
• Device Model Number: 6541-1-605
• Device Catalogue Number: 6541-1-605
• Device Lot Number: P7V50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 11/13/2020
• 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: Other
• Patient Age: 70 YR
• Patient Weight: 91