MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON SIZE 6 TIBIAL COMPONENT; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Malposition of Device (2616)

Patient Problems Loss of Range of Motion (2032); Injury (2348)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that the patient's right knee was revised due to a tight knee.X-rays revealed the tibial component was in somewhat of a valgus position.A size 6 cemented tibia (rep confirmed stryker cement was used), 12x50 stem, and 13 cs insert were revised to a size 6 universal baseplate with another 12x50 stem and an e cone, and a 6x16 cs insert.Rep provided a primary operative report and reported that x-rays, and additional information are not available.

• Brand Name: UNKNOWN TRIATHLON SIZE 6 TIBIAL COMPONENT
• Type of Device: HIP IMPLANT
• 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: 8239441
• MDR Text Key: 132777967
• Report Number: 0002249697-2019-00151
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR