MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM 15X80MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	6478-6-625
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	04/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Customer informed to sales rep that physician noticed from x-ray that the mrh press-fit stem was broken.
Event or Problem Description
Customer informed to sales rep that physician noticed from x-ray that the mrh press-fit stem was broken.
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a duracon stem was reported.The event was confirmed via evaluation of the returned device.Method & results -product evaluation and results: the fracture morphology indicates that the device failed in bending fatigue with the stem rotating counter clockwise with respect to the femoral component.Wear consistent with articulation within the femoral and tibial components were observed on the axle.Damage consistent with articulation against the femoral component was observed on the lateral side of the tibial rotating component.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.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the event was confirmed via evaluation of the returned device.Device evaluation indicated that the device failed in bending fatigue with the stem rotating counter clockwise with respect to the femoral component.Wear consistent with articulation within the femoral and tibial components were observed on the axle.Damage consistent with articulation against the femoral component was observed on the lateral side of the tibial rotating component.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.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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: TI DUR REG FLUTED STEM 15X80MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10072515
• Report Number: 0002249697-2020-00941
• Device Sequence Number: 14390634
• Product Code: JWH
• UDI-Device Identifier: 07613327044904
• UDI-Public: 07613327044904
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: No Information
• Device Expiration Date: 09/30/2019
• Device Model Number: 6478-6-625
• Device Catalogue Number: 64786625
• Device Lot Number: T3709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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: Required Intervention