MAUDE Adverse Event Report: CORENTEC CO., LTD. LOSPA TOTAL KNEE REPLACMENT SYSTEM; TOTAL KNEE REPLACEMENT SYSTEM COMPONENTS

Model Number	01.10.007
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthralgia (2355); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671)
Date of Event	09/09/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is in reference to the event described by mw5061452.Patient contacted corentec via phone call to report an event on (b)(6) 2015.Patient indicated that she had undergone a total knee arthroplasty procedure in the (b)(6) 2012 timeframe.The caller stated that her "knee was crooked and painful", and indicated that it was later revised by an alternate surgeon in the (b)(6) 2014.Patient subsequently forwarded two documents to corentec that provided surgeon information and the intraoperative device use report.The indicated catalog number on the device use report was for a lospa femoral - left implant where the intraoperative report indicated "body site: knee right', thereby raising the possibility of a discrepancy in component laterality.Corentec identified this discrepancy and initiated a product review.Device history record (dhr) was reviewed in order to confirm coincidence of lospa femoral labeling, catalog number, and quality assurance records.The implanted part and label was confirmed to be left, and it was determined that the device was manufactured to specification.Additionally, corentec requested post-operative radiographs from the patient confirming that the primary tka surgery was performed on the patient's left knee.Additionally, a review of the dhr records of the other tka components implanted was performed (tibial baseplate, tibial insert, patellar component), and determined that all were manufactured to specification.A review of corentec's customer complaint histories was undertaken and did not identify any similar events, or any other event for the reported lot.Results of this investigation were shared with the patient, and no further response was received, till date.Hence the cause of the event could not be determined due to insufficient information.Further information is required such as product return, primary and revisionary operation report along with pre/post-op x-rays, and follow-up notes for patient.No further investigation can be undertaken at this time.This report will be reopened, if additional information becomes available in the future.Additional information: mw5061452 stated six (6) device information, however device-6 - bone cement is not a product manufactured or distributed by corentec.Device-1 component patellar (part no.01.10.961) was implanted.Device-2 component patellar (part no.01.10.981) was not implanted as confirmed by the hospital's reporting sheet.Therefore, this report does not include device-2.
Event or Problem Description
The patient had a total knee replacement in (b)(6) 2012.And then, the patient stated that her knee was crooked, swollen and painful.On (b)(6) 2014, she had revision with other company's products, and was still in severe pain and trouble in walking.

• Brand Name: LOSPA TOTAL KNEE REPLACMENT SYSTEM
• Common Device Name: TOTAL KNEE REPLACEMENT SYSTEM COMPONENTS
• Manufacturer (Section D): CORENTEC CO., LTD.; 12, yeongsanhong 1-gil; ipjang-myeon, seobuk-gu; cheonan-si, chungcheongnam-do 31056 ; KS 31056
• MDR Report Key: 5693646
• Report Number: 3009106092-2016-00001
• Device Sequence Number: 179610
• Product Code: JWH
• UDI-Device Identifier: 08806373820182
• UDI-Public: 08806373820182
• Combination Product (Y/N): N
• PMA/510(K) Number: K110404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/01/2016

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: 04/30/2017
• Device Model Number: 01.10.007
• Device Catalogue Number: 01.10.007
• Device Lot Number: 111011011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2015
• Initial Report FDA Received Date: 06/01/2016
• 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: Other
• Patient Age: 56 YR