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

Model Number	6481-1-120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
It was reported the patient's left knee was revised.Original patient complaint was pain and limb length discrepancy.It was found intra-operatively, then confirmed in a pre-operative x-ray (after the patient was opened) that the lateral condyle of the femoral component was broken.Patient's entire knee was converted to a competitor construct.
Event or Problem Description
It was reported the patient's left knee was revised.Original patient complaint was pain and limb length discrepancy.It was found intra-operatively, then confirmed in a pre-operative x-ray (after the patient was opened) that the lateral condyle of the femoral component was broken.Patient's entire knee was converted to a competitor construct.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mrh femoral component was reported.The event was confirmed via product evaluation.Method & results: product evaluation and results: visual inspection of the returned device noted the following: the femoral component and stem were returned in the assembled condition.The fractured condyle was examined further using a scanning electron microscope sem.Macroscopic surface features indicate that the fracture initiated on the proximal surface and propagated toward the articulating surface.Material analysis of the returned device noted the following: the femoral component fractured in fatigue with the fracture propagating towards the articulating surface.Damage present on the articulating surface of the tibial insert is consistent with burnishing, scratching, and third body indentations.Eds showed that the femoral component was consistent with astm f75 which is consistent with the drawing.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surface examined.Clinician review: a review of the provided medical information by a clinical consultant indicated: the event cannot be confirmed based on the information provided the ap x-ray is distorted and a fracture of the implant cannot be seen.The tibial implant does appear to have loosening.To determine root cause and or confirm the event the following data would be helpful revised/removed implant for inspection operative note x-rays without distortion product history review: review of the device history records indicate 4 devices were manufactured and accepted into final stock on 11/14/2017 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: material analysis of the returned device noted the following: the femoral component fractured in fatigue with the fracture propagating towards the articulating surface.Damage present on the articulating surface of the tibial insert is consistent with burnishing, scratching, and third body indentations.Eds showed that the femoral component was consistent with astm f75 which is consistent with the drawing.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surface examined.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: MRH KNEE FEM M LFT
• 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: 10533716
• Report Number: 0002249697-2020-01878
• Device Sequence Number: 2410507
• Product Code: KRO
• UDI-Device Identifier: 07613327045154
• UDI-Public: 07613327045154
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: 11/30/2022
• Device Model Number: 6481-1-120
• Device Catalogue Number: 64811120
• Device Lot Number: C2A4B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 12/14/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR