MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS SML FEM STEM 8 X 102MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64853008

Device Problems Break (1069); Fracture (1260)

Patient Problems Pain (1994); Injury (2348)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

Patient reported a primary knee operation on (b)(6) 2016.During a follow-up with their physician, the stem was found to have a rupture.The stem is cemented to the femur.The physician found the stem appears to be curved, which is causing pain on the femur.

Manufacturer Narrative

An event regarding fracture involving an mrs stem was reported.The event was confirmed.Visual inspection of the mrs stem indicates that the stem is fractured through the shaft.Material analysis of the stem concluded that the stem fractured in fatigue.Eds showed the stem was consistent with astm f1536 alloy.No material or manufacturing defects were observed on the surfaces examined.-medical records received and evaluation:a review of the provided medical records by a clinical consultant stated the following comment: i have seen the info for this patient with a mrs femoral stem fracture at 1-year post implantation.The mar confirms a fatigue fracture without device-related aspects.There are two x-rays, one of which almost only shows the mrs/gmrs devices in the femur after a large segmental resection.The other x-ray confirms the proximal stem fracture although the cause of the problem does not become quite clear.There are some relative factors to contribute to the problem such as a relatively small diameter stem but it does still fill the present femoral canal very well, consistent with the young age of the patient (36-years) with rather thick femoral cortices.The x-rays are rather blurry and do not show very well detail.No other clinical information is available such as about the patient history and the previous surgery performed.As such, no clear diagnosis about the failure mode can be established and this case needs more info to solve, especially clinical information plus more and better quality x-rays.So, the only positive information available is that no device-related factors were present according to the mar which leaves failure mode probably as an adverse mix of patient-related and procedure-related factors about which there is currently not enough information to further detail and differentiate these aspects.-device history review: indicated that the devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: indicated that there have been no other similar reported events for the lot referenced.Visual inspection of the mrs stem indicates that the stem is fractured through the shaft.Material analysis of the stem concluded that the stem fractured in fatigue.Eds showed the stem was consistent with astm f1536 alloy.No material or manufacturing defects were observed on the surfaces examined.Based on clinician review of the x-rays provided the investigation indicated that the x-rays provided are rather blurry and do not show very well detail.No other clinical information is available such as about the patient history and the previous surgery performed.As such, no clear diagnosis about the failure mode can be established and this case needs more info to solve, especially clinical information plus more and better quality x-rays.So, the only positive information available is that no device-related factors were present according to the mar which leaves failure mode probably as an adverse mix of patient-related and procedure-related factors about which there is currently not enough information to further detail and differentiate these aspects.No further investigation is possible at this time.If additional information become available such as better quality x-rays, patient history and further clinical information, this investigation will be reopened.

Event Description

Patient reported a primary knee operation on (b)(6) 2016.During a follow-up with their physician, the stem was found to have a rupture.The stem is cemented to the femur.The physician found the stem appears to be curved, which is causing pain on the femur.

• Brand Name: MRS SML FEM STEM 8 X 102MM
• Type of Device: 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
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6862730
• MDR Text Key: 86076768
• Report Number: 0002249697-2017-02755
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K040749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

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: 05/01/2019
• Device Catalogue Number: 64853008
• Device Lot Number: 131874C1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 50