MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE6 BP; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5526B600

Device Problems Malposition of Device (2616); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned.

Event Description

A knee revision was reported for instability.

Event Description

A knee revision was reported for instability.Update: med review received, clinician states: 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 bearing causing poly wear and metallosis due to metal-metal contact between femur and tibia.

Manufacturer Narrative

An event regarding malposition and metallosis involving a triathlon baseplate was reported.The event was confirmed through clinician review of the medical records provided.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar)it states: damage was observed on the proximal surface of the baseplate, consistent with contact against the femoral component.Biological fixation was observed on the distal surface of the baseplate.The mar 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: the medical review indicated: 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 bearing causing poly wear and metallosis due to metal-metal contact between femur and tibia requiring revision after 5-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.Conclusion: the medical review indicated 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 bearing causing poly wear and metallosis due to metal-metal contact between femur and tibia requiring revision after 5-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.

• Brand Name: TRIATHLON PRIM BEAD PA SZE6 BP
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7529589
• MDR Text Key: 108750575
• Report Number: 0002249697-2018-01499
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 5526B600
• Device Lot Number: EB6MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 07/25/2018
• Supplement Dates FDA Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 95