MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS EXTENSION PIECE 140MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6495-6-140
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
Additional Manufacturer Narrative
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.
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.
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
Reported event: an event regarding corrosion involving a gmrs extension piece was reported.The event was confirmed via evaluation of the returned devices.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: "figure shows discolouration within the female taper of the proximal end of the extension piece, consistent with in-vivo wear.Mechanical damage was also observed on the outer surface of the extension piece likely a result of explantation damage." 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." 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: GMRS EXTENSION PIECE 140MM
• 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 ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16782291
• Report Number: 0002249697-2023-00402
• Device Sequence Number: 5436001
• Product Code: KRO
• UDI-Device Identifier: 07613327049275
• UDI-Public: 07613327049275
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023087
• 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: 07/31/2015
• Device Model Number: 6495-6-140
• Device Catalogue Number: 64956140
• Device Lot Number: LBHTX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2010
• 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: 54 YR
• Patient Sex: Male