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

Catalog Number	64753933
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem 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
• Common Device Name: KNEE JOINT FEMOROTIBIAL METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7945675
• Report Number: 0002249697-2018-03237
• Device Sequence Number: 856649
• Product Code: LGE
• UDI-Device Identifier: 07613327046656
• UDI-Public: 07613327046656
• Combination Product (Y/N): N
• PMA/510(K) Number: K811630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 64753933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR