MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #5L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5517-F-501
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event an event regarding size/fit issue involving a triathlon femoral component was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-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 exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During a mako tkr the final implant did not fit well.Resulting in a cemented femur being used.Cemented femur: lot c7x9y.During the case all cuts were checked with the planar probe with good results.

• Brand Name: TRIATHLON P/A CR BEADED #5L
• 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: 9763296
• Report Number: 0002249697-2020-00408
• Device Sequence Number: 13625214
• Product Code: MBH
• UDI-Device Identifier: 07613327040982
• UDI-Public: 07613327040982
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 5517-F-501
• Device Catalogue Number: 5517F501
• Device Lot Number: H3S7B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/27/2020
• 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: Other
• Patient Age: 71 YR