MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-600
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	07/23/2018
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 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 it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that patient's left knee was revised due to suspected avascular necrosis of the patient's tibia.The tibial baseplate was reported collapsed medially.Examination notes from (b)(6) 2018 state that the patient reported clicking, difficulty walking, and pain.Those notes also report gross varus deformity of the left knee with diabetes as a patient factor.Patient was revised to a ts construct (patella was not revised).
Additional Manufacturer Narrative
An event regarding subsidence involving a triathlon baseplate was reported.The event was confirmed by the operative note provided.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: insufficient medical records were provided for medical review.Operative notes, patient clinical notes, histopathology, serial x-rays, and examination of the explanted components are required to complete the medical review.-product 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.Conclusion: the operative note provided revealed failed total knee replacement, suspect avascular necrosis, medical tibial plateau with gross tibial component collapse.However the exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as operative notes, patient clinical notes, histopathology, serial x-rays, and examination of the explanted components 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
It was reported that patient's left knee was revised due to suspected avascular necrosis of the patient's tibia.The tibial baseplate was reported collapsed medially.Examination notes from april 2018 state that the patient reported clicking, difficulty walking, and pain.Those notes also report gross varus deformity of the left knee with diabetes as a patient factor.Patient was revised to a ts construct (patella was not revised).

• Brand Name: TRI TS BASEPLATE SIZE 6
• 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: 7797878
• Report Number: 0002249697-2018-02574
• Device Sequence Number: 13972114
• Product Code: MBH
• UDI-Device Identifier: 07613327026337
• UDI-Public: 07613327026337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/21/2018

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: 08/31/2020
• Device Catalogue Number: 5521-B-600
• Device Lot Number: SR4Z
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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: 62 YR
• Patient Weight: 122