MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #1; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5520B100
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding arthrofibrosis involving a triathlon baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.The device remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there were no other similar events for the lot referenced.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as product return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required 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
The patient underwent left total knee replacement (b)(6) 2018.Patient had mechanical failure left knee arthrofibrosis and underwent left knee revision only tibial and patellar components exchanged (b)(6) 2018.".
Event or Problem Description
The patient underwent left total knee replacement 1/25/2018.Patient had mechanical failure left knee arthrofibrosis and underwent left knee revision only tibial and patellar components exchanged (b)(6) 2018.".
Additional Manufacturer Narrative
An event regarding arthrofibrosis involving a triathlon baseplate was reported.The event was confirmed based on clinician review of the medical records provided.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.The device remains implanted.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirms revision of a primary cemented tka for pain and dysfunction occurred.The cause of this pain and dysfunction was reported to be caused by arthrofibrosis ¿ an excessive scar tissue response which can lead to restriction of joint motion and pain.The root cause for the development of arthrofibrosis is unknown.No mechanical complication is identified.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there were no other similar events for the lot referenced.Conclusions: a review of the provided medical records and x-rays by a clinical consultant confirms revision of a primary cemented tka for pain and dysfunction occurred.The cause of this pain and dysfunction was reported to be caused by arthrofibrosis ¿ an excessive scar tissue response which can lead to restriction of joint motion and pain.The root cause for the development of arthrofibrosis is unknown.No mechanical complication is identified.Further information such as further medical records is required to complete the investigation for determining a root cause.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #1
• 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: 7971379
• Report Number: 0002249697-2018-03401
• Device Sequence Number: 16537055
• Product Code: MBH
• UDI-Device Identifier: 07613327041040
• UDI-Public: 07613327041040
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 11/30/2022
• Device Catalogue Number: 5520B100
• Device Lot Number: C9R7L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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: 74 YR
• Patient Weight: 54