MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 13MMX203MM FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6485-3-313
Medical Device Problem Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Insufficient Information (4580)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Broken 203x13mm curved gmrs stem in situ in patient.Revision surgery required.Surgeon reported that while the patient was walking, they felt their leg buckle.Fractured component confirmed by x-ray.
Additional Manufacturer Narrative
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.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 returned.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and corrosion involving a mrs stem was reported.The event was confirmed via evaluation of the returned devices and clinician review of the provided medical records.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis and indicated the following: "image shows the mrs curved stem with fracture location highlighted by the arrow.On visual examination, the fracture was observed approximately 28 mm from the male taper end of the stem." material analysis: a material analysis was performed which concluded the following: "review of mrs curved stem, catalogue # 6485-3-313, lot code tec659 and gmrs extension piece, catalogue # 6495-6-140, lot code lbhtx, confirmed fracture of the stem.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the mrs curved stem near the male taper.The device fractured in fatigue and the fracture initiated at or near the location of laser marking on the stem.Energy dispersive spectroscopy confirmed oxidation of both components in the discoloured regions, indicating corrosion, consistent with in-vivo wear." -clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: a fracture occurred through a cemented long stem modular tumor style revision knee implant.The failure occurred through the threaded junction to the stem-extension towards the knee.Event confirmation: the event, a broken implant, was confirmed.Root cause: a root cause cannot be ascertained without additional medical information." -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 fracture of the mrs stem.A material analysis was performed which concluded the following: "review of mrs curved stem, catalogue # 6485-3-313, lot code tec659 and gmrs extension piece, catalogue # 6495-6-140, lot code lbhtx, confirmed fracture of the stem.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the mrs curved stem near the male taper.The device fractured in fatigue and the fracture initiated at or near the location of laser marking on the stem.Energy dispersive spectroscopy confirmed oxidation of both components in the discoloured regions, indicating corrosion, consistent with in-vivo wear." the event was further confirmed by clinician review of the provided x-ray image.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.
Event or Problem Description
Broken 203x13mm curved gmrs stem in situ in patient revision surgery required surgeon reported that while the patient was walking, they felt their leg buckle.Fractured component confirmed by x-ray.

• Brand Name: MRS 13MMX203MM FEMORAL STEM
• 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; centennial park, elstree; limerick WD6 3-SJ ; EI WD6 3SJ ; 61498200
• MDR Report Key: 16625696
• Report Number: 0002249697-2023-00316
• Device Sequence Number: 4474474
• Product Code: KRO
• UDI-Device Identifier: 07613327048452
• UDI-Public: 07613327048452
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: 04/30/2013
• Device Model Number: 6485-3-313
• Device Catalogue Number: 64853313
• Device Lot Number: TEC659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2008
• 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: 54 YR
• Patient Sex: Male