MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 11MM X 127MM FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64853011

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

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.A supplemental report will be submitted upon completion of the investigation.

Event Description

As reported: "the original 11 x 127 femoral stem broke.During the revision we explanted the broken stem and replaced it".

Manufacturer Narrative

An event regarding crack/fracture involving a mrs stem was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 15 august 2018.The parts were examined with the aid of a stereo microscope at magnifications up to 50x.The stem fractured approximately 4 inches from the distal tip.The fracture surfaces associated with the proximal end and distal tip.The mar concluded: the stem fractured in fatigue.Eds showed the stem was consistent with astm f1537 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records indicated: i have seen the x-rays for this patient with a fractured femoral gmrs stem extender.The fracture is confirmed and localised approximately 6-cm proximal of the femoral anchoring body.Otherwise the gmrs arthroplasty appears very adequate for size, position and quality of reconstruction.The x-rays lack detail due to low resolution while time of implantation is not reported and no other clinical information is available.As such can this case not be solved adequately with the current information.No obvious procedure-related issues are evident.Bone contact between device and bone in the fracture area still appears okay.Loss of device-bone contact is the usual cause for such fractures but not evident in this patient.It is possible that a long implantation time has just caused an end of normal service life condition.There is a very large segmental defect on the femoral side, probably after tumour resection, bridged with a long extension piece, so could quite well represent the cause of the problem because the load condition is extreme even under optimal implantation conditions.This patient is now (b)(6) years while most malignant bone tumours occur at much lower age ranges.More info and higher resolution x-rays might provide better insight to the type of problem.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the mar concluded: the stem fractured in fatigue.Eds showed the stem was consistent with astm f1537 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The medical review indicated: i have seen the x-rays for this patient with a fractured femoral gmrs stem extender.The fracture is confirmed and localised approximately 6-cm proximal of the femoral anchoring body.Otherwise the gmrs arthroplasty appears very adequate for size, position and quality of reconstruction.The x-rays lack detail due to low resolution while time of implantation is not reported and no other clinical information is available.As such can this case not be solved adequately with the current information.No obvious procedure-related issues are evident.Bone contact between device and bone in the fracture area still appears okay.Loss of device-bone contact is the usual cause for such fractures but not evident in this patient.It is possible that a long implantation time has just caused an end of normal service life condition.There is a very large segmental defect on the femoral side, probably after tumour resection, bridged with a long extension piece, so could quite well represent the cause of the problem because the load condition is extreme even under optimal implantation conditions.This patient is now (b)(6) years while most malignant bone tumours occur at much lower age ranges.Further information such as higher resolution x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As reported: "the original 11 x 127 femoral stem broke.During the revision we explanted the broken stem and replaced it".

• Brand Name: MRS 11MM X 127MM FEMORAL STEM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7704129
• MDR Text Key: 114485736
• Report Number: 0002249697-2018-02245
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327048322
• UDI-Public: 07613327048322
• Combination Product (y/n): N
• PMA/PMN Number: K040749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Catalogue Number: 64853011
• Device Lot Number: TEC320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 08/22/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR