MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #5L; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	5517F501
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	12/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: no medical records were received for review with a clinical consultant.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot information and return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had a primary total knee with a pressfit femur and a cemented tibia done approximately 8 years ago.He did fine until recently.He developed lateral pain.Cat scan showed some lucency.He was scheduled for a revision of the femur.The femoral component was removed with thin osteotomes.There was significant "boney" ingrowth with one area on the lateral side with fibrous growth.The tibia and patellar were solid and left intact.The femur was converted to a cemented ps.The patellar tracked well and the knee was well balanced.The operation was completed successfully.

• Brand Name: TRIATHLON P/A CR BEADED #5L
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8261367
• Report Number: 0002249697-2019-00229
• Device Sequence Number: 2081692
• Product Code: JWH
• UDI-Device Identifier: 07613327040982
• UDI-Public: 07613327040982
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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 Catalogue Number: 5517F501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2018
• Initial Report FDA Received Date: 01/18/2019
• 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: 65 YR
• Patient Weight: 68