MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5515-F-301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	05/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Sales rep reported a primary surgery of knee which the femoral condyle broke during the surgery.Surgeon put a notch in the femur (take away some of the bone) to make the implant fit.It did fit as it was being tapped and broke the lateral condyle.Surgeon reimplanted a stryker component in place and used a competitor's screws.
Additional Manufacturer Narrative
An event regarding intraop fracture involving a triathlon femoral component was reported.The event was not confirmed.Device evaluation and results: material analysis is not performed as this is not related to material integrity.No damages observed on the device.Medical records received and evaluation: no patient medical records were available for review.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the event reported a primary surgery of knee which the femoral condyle broke during the surgery.The event could not be confirmed nor the root cause determined as sufficient information was not provided.Further information such as pre and post operative x-rays, medical records, operative reports, full patient history as well as follow up notes are needed to complete the investigation for determining a root cause.Material analysis is not performed as this is not related to material integrity.No damages observed on the device.If the additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Sales rep reported a primary surgery of knee which the femoral condyle broke during the surgery.Surgeon put a notch in the femur (take away some of the bone) to make the implant fit.It did fit as it was being tapped and broke the lateral condyle.Surgeon reimplanted a stryker component in place and used a competitors screws.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• 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: 6611547
• Report Number: 0002249697-2017-01768
• Device Sequence Number: 10766917
• Product Code: MBH
• UDI-Device Identifier: 07613327050356
• UDI-Public: (01)07613327050356(11)161004(17)211004(10)WLVZD
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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: 10/04/2021
• Device Model Number: 5515-F-301
• Device Catalogue Number: 5515-F-301
• Device Lot Number: WLVZD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 09/19/2017
• 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: Other
• Patient Age: 67 YR