MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMP #2L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5515F201
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that after implantation, patient complained of pain.A ct scan revealed a condylar fracture to femoral pin side.Surgeon has not determined a method of resolution as of the time of report.
Additional Manufacturer Narrative
An event regarding a periprosthetic fracture involving a triathlon femoral component was reported.The event was confirmed through medical review.Method & results: device evaluation and results: not performed as the product was not returned.It remains implanted.Medical records received and evaluation: suboptimal location of a computer navigation pinhole very close to or in the lateral femoral cortex has caused a local weak spot with expansion to a periprosthetic fracture close to a triathlon femoral device.No specific fracture treatment has been reported thus far.Device 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 reported events for the lot referenced.Conclusion: the medical review indicated suboptimal location of a computer navigation pinhole very close to or in the lateral femoral cortex has caused a local weak spot with expansion to a periprosthetic fracture close to a trioathlon femoral device.No specific fracture treatment has been reported thus far.The femoral component reported in this complaint investigation is not associated with the fracture because the fracture was related to the navigation pinhole.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 or Problem Description
It was reported that after implantation, patient complained of pain.A ct scan revealed a condylar fracture to femoral pin side.Surgeon has not determined a method of resolution as of the time of report.

• Brand Name: TRIATHLON PS FEM COMP #2L-CEM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7326511
• Report Number: 0002249697-2018-00680
• Device Sequence Number: 151158
• Product Code: MBH
• UDI-Device Identifier: 07613327040708
• UDI-Public: 07613327040708
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 5515F201
• Device Lot Number: AXT2C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 05/07/2018
• 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: 60 YR