MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5530-G-611
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding revision due to pain involving a triathlon insert was reported.The event was not confirmed.Method and results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted insert with nothing remarkable to report.Medical records received and evaluation: a review of the provided medical records x-rays by a clinical consultant indicated: soft tissue imbalance in the extensor tendon mechanism of the knee contributed to lateral tilt/shift of the patellar device with overload on the remaining contact sections with poly wear and damage becoming evident causing anterior knee pain requiring revision surgery with exchange of the patellar device and tibial bearing exchange for access reasons to the knee.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: the investigation concluded that: soft tissue imbalance in the extensor tendon mechanism of the knee contributed to lateral tilt/shift of the patellar device with overload on the remaining contact sections with poly wear and damage becoming evident causing anterior knee pain requiring revision surgery with exchange of the patellar device and tibial bearing exchange for access reasons to the knee.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
As reported: "pain in anterior knee.Poly swap while in knee.All available information submitted".Explant pictures show that the patellar implant suffered visible damage.Patient was revised to a 6/11 cr insert and an a35 x3 patella.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 7611383
• Report Number: 0002249697-2018-01862
• Device Sequence Number: 18877939
• Product Code: MBH
• UDI-Device Identifier: 07613327050592
• UDI-Public: 07613327050592
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: 05/31/2014
• Device Catalogue Number: 5530-G-611
• Device Lot Number: MHHM8Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/18/2018
• 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: 114