MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F301
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Date of Event	03/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding a periprosthetic fracture involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed because the device was not returned for evaluation.-medical records received and evaluation: not performed as medical records were not provided.-device history review: the device was 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.Conclusions: the exact cause of the event could not be determined due to insufficient provision of information.Further information such as evaluation of device, x-rays, operative reports as well as patient history and follow up notes are needed to complete the investigation to determine a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not available.
Event or Problem Description
It was reported that patient's left knee was revised after falling and sustaining a periprosthetic fracture of the femoral condyle (rep reported patient has limited mobility due to having ms and had another post-op fall previously).

• Brand Name: TRIATHLON CR FEM COMP #3 L-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: 7493536
• Report Number: 0002249697-2018-01348
• Device Sequence Number: 1704945
• Product Code: MBH
• UDI-Device Identifier: 07613327040258
• UDI-Public: 07613327040258
• 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 Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: 09/30/2022
• Device Catalogue Number: 5510F301
• Device Lot Number: C4X2A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/08/2018
• 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: 63 YR
• Patient Weight: 90