MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #3R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F302
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060); Injury (2348)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient had tk on (b)(6) 2017.Could not get full extension.A revision of femoral component was performed.
Additional Manufacturer Narrative
An event regarding revision due to poor range of motion involving a triathlon femoral component was reported.The event was not confirmed.Device evaluation and results: not performed as the device was not returned.The medical review comment indicated a review of the provided x rays by a clinical consultant indicated the only information is a lateral x-ray of the knee, actually two identical lateral views are available without an ap view.This shows an adequate implantation of the femoral as well as tibial component for size and position.All relevant anatomic markers are within range with no obvious explanation for the lack of extension of the patient.Also the patella component has a normal appearance.Scar tissue formation with limitation in knee function is far from rare after knee arthroplasty, at times requiring manipulation of the knee under anaesthesia within the first few months.Revision of the femur would suggest that malposition might have played a role but this is not evident on the lateral view.It could be possible that more clues to the problem would be evident from the corresponding ap view but this is not available for review.As there is also no clinical or other information available, this case cannot be solved with the current information.Device history review: indicated 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 lot referenced.The medical review comment indicated a review of the provided x rays by a clinical consultant indicated the only information is a lateral x-ray of the knee, actually two identical lateral views are available without an ap view.This shows an adequate implantation of the femoral as well as tibial component for size and position.All relevant anatomic markers are within range with no obvious explanation for the lack of extension of the patient.Also the patella component has a normal appearance.Scar tissue formation with limitation in knee function is far from rare after knee arthroplasty, at times requiring manipulation of the knee under anaesthesia within the first few months.Revision of the femur would suggest that malposition might have played a role but this is not evident on the lateral view.It could be possible that more clues to the problem would be evident from the corresponding ap view but this is not available for review.As there is also no clinical or other information available, this case cannot be solved with the current information.The exact cause of the event could not be determined as insufficient information was provided further information such as product return, ap view x rays, operative reports as well as patient history and follow up notes are needed 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 tk on (b)(6) 2017.Could not get full extension.A revision of femoral component was performed.

• Brand Name: TRIATHLON P/A CR BEADED #3R
• 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: 7306481
• Report Number: 0002249697-2018-00584
• Device Sequence Number: 1261026
• Product Code: MBH
• UDI-Device Identifier: 07613327040951
• UDI-Public: 07613327040951
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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: 03/31/2022
• Device Catalogue Number: 5517F302
• Device Lot Number: BNA7E1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/18/2018
• 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: 76 YR
• Patient Weight: 68