MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE4 BP; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5526B400
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding malposition leading to instability involving a triathlon insert was reported.The event was confirmed through the device return and analysis.Method and results: device evaluation and results: a material analysis has been performed.The report concluded: damage was observed on the femoral component, insert and baseplate consistent with contact against each other.Debris was observed on the insert, likely from the femoral component.Eds showed the femoral component, baseplate and debris were consistent with astm f75 alloy.Burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Explantation damage and markings consistent with contact against the baseplate were also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: baseplate malposition in excessive posterior tibial slope has caused flexion instability of the knee with the femoral component riding over the posterior border of the baseplate with poly bearing causing poly wear and metallosis due to metal-metal contact between femur and tibia requiring revision after 7-years.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.Conclusions: material analysis concluded: damage was observed on the femoral component, insert and baseplate consistent with contact against each other.Debris was observed on the insert, likely from the femoral component.Eds showed the femoral component, baseplate and debris were consistent with astm f75 alloy.Burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Explantation damage and markings consistent with contact against the baseplate were also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The medical review concluded that baseplate malposition in excessive posterior tibial slope has caused flexion instability of the knee with the femoral component riding over the posterior border of the baseplate with poly bearing causing poly wear and metallosis due to metal-metal contact between femur and tibia requiring revision after 7-years.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
Knee revision due to instability.Update based on med review: baseplate malposition in excessive posterior tibial slope has caused flexion instability of the knee with the femoral component riding over the posterior border of the baseplate with poly bearing causing poly wear and metallosis due to metal-metal contact between femur and tibia requiring revision after 7-years.

• Brand Name: TRIATHLON PRIM BEAD PA SZE4 BP
• 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: 7874091
• Report Number: 0002249697-2018-02858
• Device Sequence Number: 18878427
• Product Code: MBH
• UDI-Device Identifier: 07613327041354
• UDI-Public: 07613327041354
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2018

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: 05/31/2016
• Device Catalogue Number: 5526B400
• Device Lot Number: S36DC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/13/2018
• 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: 64 YR
• Patient Weight: 89