MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5532-G-313
Medical Device Problem Codes	Unstable (1667); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	12/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding audible noise involving a triathlon insert 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: a review of the provided medical records by a clinical consultant indicated: on (b)(6) 2018 a note states, ¿seen (b)(6) 2018 and diagnosed with unstable right tkr ¿ reports ascending and descending stairs virtually impossible ¿ reports clicking sound and sensation with weight bearing.Physical examination: 0° to 120° with jog of laxity in full extension and 90° ¿ ap drawer test negative.Plan: bledsoe brace, strengthening exercises, return in two months.¿ no documented follow-up subsequent to this visit is available.X-ray printouts include multiple views of the right knee, all undated, demonstrating a right posterior stabilized total knee arthroplasty, uncemented, with four screws in the tibial baseplate.The knee is reduced and the components are in nominal position.There is no evidence of loosening or pathology noted.The event description states, ¿¿ she reports having clicks while walking and has ¿ weakness, swelling, and buckling wearing a knee brace for support and can no longer hear the clicking.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: it is also noted that the patient inquired if the product was part of the recall.A letter from stryker orthopedics dated october 29, 2018 states, ¿none of these products have been involved in a recall.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 through mw5078695: "patient reports she was unable to get up from her bed one morning due to severe pain in her knee.She reports hearing clicks while walking and has experienced weakness, swelling and buckling.Her orthopedic surgeon saw "something sticking out of her bone" and mentioned that "something pulls away" when she moves her knee.Patient is worried her implant may have been recalled.The patient is wearing a knee brace for support and can no longer hear the clicking noise; however, her other symptoms persist." updated as per medical review.On (b)(6) 2018 a note states, ¿seen (b)(6) 2018 and diagnosed with unstable right tkr ¿ reports ascending and descending stairs virtually impossible ¿ reports clicking sound and sensation with weight bearing.Physical examination: 0° to 120° with jog of laxity in full extension and 90° ¿ ap drawer test negative.Plan: bledsoe brace, strengthening exercises, return in two months.¿.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8229119
• Report Number: 0002249697-2019-00107
• Device Sequence Number: 19399831
• Product Code: MBH
• UDI-Device Identifier: 07613327050653
• UDI-Public: 07613327050653
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

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 Expiration Date: 06/30/2016
• Device Catalogue Number: 5532-G-313
• Device Lot Number: MKJNE9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/08/2019
• 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: 85 YR
• Patient Weight: 61