MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH KMAX STEM EXTNR(S,M,L,XL)155MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-1-131
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	12/18/2019
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
Surgeon revised a modular rotating hinge knee today as the femoral component¿s stem boss had fractured.He revised it to a gmrs distal femur replacement.2hrs surgical delay.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a kinemax stem was reported.The event was confirmed.Method & results: device evaluation and results: the female threads from the femoral component were returned assembled to the male threads of the femoral stem.Cement was observed on the distal portion of the device.The female threads were fractured longitudinally and transversely.The fracture morphology of the femoral component is consistent with a fatigue fracture.Eds and xrf showed that the femoral component, axle, stem, and tibial rotating component were consistent with their respective drawings.Clinician review: a review of the provided x-rays by a clinical consultant indicated: x-ray print outs.All undated: include 2 lat.1ap and 1 oblique view of the right knee demonstrating a cemented long stem hinge tka with both stems intact and well fixed in cement.The modular tibial stem is longer than the specimens photo described.No clinical or pmh, no operative reports or dates of surgery, no examination of explanted components and no dated serial x-rays available.Based upon the information offered for review, no medical report regarding the alleged event description is possible for this case.Device history review: all 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 reported lot.Conclusion: the fracture morphology of the femoral component is consistent with a fatigue fracture.Eds and xrf showed that the femoral component, axle, stem, and tibial rotating component were consistent with their respective drawings.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces.
Event or Problem Description
Surgeon revised a modular rotating hinge knee today as the femoral component¿s stem boss had fractured.He revised it to a gmrs distal femur replacement.2hrs surgical delay.

• Brand Name: KMAX STEM EXTNR(S,M,L,XL)155MM
• 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: 9593586
• Report Number: 0002249697-2020-00107
• Device Sequence Number: 595600
• Product Code: KRO
• UDI-Device Identifier: 07613327045376
• UDI-Public: 07613327045376
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: 11/30/2017
• Device Model Number: 6481-1-131
• Device Catalogue Number: 64768270
• Device Lot Number: CTD2689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 06/07/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 07/02/2020
• 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: 86 YR
• Patient Weight: 76