MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5520-B-300

Device Problem Osseointegration Problem (3003)

Patient Problems Fall (1848); Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

An event regarding subsidence involving a triathlon baseplate was reported.The event of subsidence was confirmed by the clinician review.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant was rejected stating - "provided x-rays confirm subsidence into varus.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot.Conclusions: it was reported that the patient complained of pain and had a tibial loosening.The available medical records were provided to the consulting clinician for a review which was rejected stating provided x-rays confirm subsidence into varus.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.The exact cause of the event could not be determined because insufficient information was available.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient had a total knee replacement (b)(6) 2018.She had an unremarkable recovery.She subsequently had a fall.She did not come in after that till her annual check up.She complained of pain.The xray showed that she had tibial loosening.She was scheduled for revision surgery.She was revised (b)(6) 2019.The operation was completed successfully.The surgeon alleges no defect of the implants and attributes the loosening to her previous fall.Update 19/march/2019: a size 3 ps femur, size 3 tibial baseplate, and 3x9 ps insert were revised to a ts construct with stems and 4 augments.Rep provided pre-revision x-rays, primary and revision implant sheets and reported that no further information is available.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8514791
• MDR Text Key: 141949313
• Report Number: 0002249697-2019-01599
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050318
• UDI-Public: 07613327050318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 5520-B-300
• Device Lot Number: BBZ3ZA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 66