MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5536B500

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646); Fibrosis (3167)

Event Date 07/25/2014

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

This pi is for revision of primary in (b)(6) 2014.In reporting a revision of the patient's left knee in (b)(6) 2019, rep provided an operative report for a revision in (b)(6) 2014.The operative report states "preoperative diagnoses: painful right total knee arthroplasty.Probable loosening of tibial component, pain in the right knee, mostly in the proximal right lower leg.X-rays had shown development of an osteolytic area under the medial tibial plateau with a sclerotic halo about the tibial knee.The overall appearance was consistent with loosening.The tibial component was not grossly loose, but following retrieval and inspection of the undersurface of the base plate, there did not appear to be any bone ingrowth.There was considerable fibrosis ingrowth, however.My suspicion is that the patient had osteonecrosis of the medial tibial plateau, probably following a stress or insufficiency fracture in the metaphyseal bone.

• Brand Name: TRITANIUM BPLATE TRIATHLON S5
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8675470
• MDR Text Key: 147216988
• Report Number: 0002249697-2019-02183
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041507
• UDI-Public: 07613327041507
• 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: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 5536B500
• Device Lot Number: ECTHF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2013
• 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: 65 YR
• Patient Weight: 94