MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #1L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F101
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.The incorrect femoral component was chosen due to human error during primary implantation which led to the revision of an insert to create a compatible construct.The femoral component was not revised.The femoral component is being reported as serious injury as it was the cause for the revision and the triathlon ps x3 tibial insert; cat# 5532-g-216; lot# 791t5r is being deemed not reportable as there were no issues with or allegations made against the insert.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
This event is for the same-day revision of patient's knee.The incorrect femoral component was implanted due to human error.They revised the patient the same day and left the cr femur implanted but exchanged the ps insert to a cs insert to adjust for the femoral error so that the surgeon was satisfied with the patient¿s knee construct.
Event or Problem Description
This event is for the same-day revision of patient's knee.The incorrect femoral component was implanted due to human error.They revised the patient the same day and left the cr femur implanted but exchanged the ps insert to a cs insert to adjust for the femoral error so that the surgeon was satisfied with the patient¿s knee construct.
Additional Manufacturer Narrative
An event regarding incorrect selection involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no product was returned for evaluation.-medical records received and evaluation: not performed as no medical records were provided for review.-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 events for the lot referenced.Conclusion: based on the provided information the incorrect femoral component was implanted due to human error.Revision surgery was performed on the same day the ps insert was revised to a cs insert to adjust for the femoral error, the femoral component was not revised.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON P/A CR BEADED #1L
• 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: 7614352
• Report Number: 0002249697-2018-01871
• Device Sequence Number: 1946318
• Product Code: MBH
• UDI-Device Identifier: 07613327041606
• UDI-Public: 07613327041606
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/02/2018

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: 11/30/2021
• Device Catalogue Number: 5517F101
• Device Lot Number: BRC3T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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: 67 YR
• Patient Weight: 68