MAUDE Adverse Event Report: CORENTEC CO., LTD. LOSPA KNEE SYSTEM; PROSTHESIS, KNEE

Model Number	01.10.064
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history records (dhrs) for the device and concomitant products were reviewed and no discrepancies relevant to the reported event were found.Since the similar case with the reported event was not found during customer complaints history review, no further actions are required, but monitoring the trends is required.Once any supplemental information is found which would change any information or conclusions, additional information will be filed accordingly.We were told that the patient got the revision knee case with other manufacturer's device the other day.The explanted device was not returned.
Event or Problem Description
It was reported that patient dislocated six days after the knee arthroplasty.The femur dislocated from the baseplate while the patient was pulling up the stockings sitting on the bed.

• Brand Name: LOSPA KNEE SYSTEM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): CORENTEC CO., LTD.; 12, yeongsanhong 1-gil; ipjang-myeon, seobuk-gu; cheonan-si, chungcheongnam-do 31056 ; KS 31056
• MDR Report Key: 7863456
• Report Number: 3009106092-2018-00001
• Device Sequence Number: 1939435
• Product Code: JWH
• UDI-Device Identifier: 08806373820540
• UDI-Public: (01)08806373820540(17)220428(10)6BAGEY04
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2018

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 Expiration Date: 04/28/2022
• Device Model Number: 01.10.064
• Device Catalogue Number: 01.10.064
• Device Lot Number: 6BAGEY04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOSPA PATELLAR COMPONENT 30MM (CAT NO. 01.10.961); LOSPA TIBIAL BASEPLATE SIZE 4 (CAT NO. 01.10.504); LOSPA TIBIAL INSERT SIZE 4 (CAT NO. 01.10.24A)
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 76 YR