MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ4 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5512-F-402
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon ts femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that revision surgery took place due to loosening of the femoral components.A size 4 femoral component along with a press-fit stem and a size 7 28mm insert were removed.The event could not be confirmed with the information provided.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Not returned to the manufacturer.
Event or Problem Description
It was reported patient's right knee was revised due to loosening of the femoral components.A size 4 femoral component along with a press-fit stem which was cemented in (manufacturer of cement unknown) along with a size 7 28mm insert were removed.

• Brand Name: TRI TS FEMUR SZ4 RIGHT
• 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: 7927302
• Report Number: 0002249697-2018-03148
• Device Sequence Number: 1449425
• Product Code: MBH
• UDI-Device Identifier: 07613327026085
• UDI-Public: 07613327026085
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

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: 06/30/2016
• Device Catalogue Number: 5512-F-402
• Device Lot Number: DUER
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 10/02/2018
• 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: 70 YR
• Patient Weight: 93