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 Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Pain (1994); Swelling (2091); Thyroid Problems (2102); Ambulation Difficulties (2544)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

It's alleged by the patient through the filing of a claim that she underwent a total knee arthroplasty on an unknown date.It is further alleged that after implantation the patient began experiencing "pain, swelling, difficulty walking, nerve damage, thyroid problems, shin conditions and high levels of cobalt and chromium".¿on (b)(6) 2007 the patient was admitted for "left hip pain.Few months.Complains of mild discomfort right knee.With 110° of flexion.Plan: left total hip arthroplasty and manipulation under anesthesia right knee.Uses tobacco products." on (b)(6) 2007 there is an operative report for a closed manipulation under anesthesia of the right knee and a left total hip arthroplasty for a diagnosis of "left hip arthrosis and post-operative arthrofibrosis right tka".The operative report notes spinal anesthesia and a posterolateral approach for the hip.Prior to the hip arthroplasty a manipulation under anesthesia of the right knee was performed for a pre-operative range of motion noted to be 0° to 85° and post manipulation it was noted to be "well over 120° of flexion".¿.

• 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: merin grace ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7768753
• MDR Text Key: 116624570
• Report Number: 0002249697-2018-02454
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2011
• Device Catalogue Number: 5520-B-300
• Device Lot Number: UHZY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2005
• 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): Other