MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL COMP KIN HINGE KNEE; KNEE JOINT FEMOROTIBIAL METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 64753933

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

On (b)(6) 2018, there was no problem when visiting outpatients in the morning.My knee suddenly became unstable from the afternoon and went to a nearby hospital.Visited the original hospital again after observing about 3 months.On september 27, 2018, it was confirmed that reoperation was carried out and it was broken.

• Brand Name: TIBIAL COMP KIN HINGE KNEE
• Type of Device: KNEE JOINT FEMOROTIBIAL METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7945675
• MDR Text Key: 123045448
• Report Number: 0002249697-2018-03237
• Device Sequence Number: 1
• Product Code: LGE
• UDI-Device Identifier: 07613327046656
• UDI-Public: 07613327046656
• Combination Product (y/n): N
• PMA/PMN Number: K811630
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 64753933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2018
• 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: 60 YR