MAUDE Adverse Event Report: CORENTEC CO., LTD. BENCOX PE LINER 36/44; ACETABULAR PE LINER

Model Number	01.02.643
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient hyperflexed his left hip, and the surgeon reduced the dislocation under fluoroscopy on (b)(6) 2016.Revision surgery was performed for continued hip instability on (b)(6) 2016.It was confirmed that the existing pe liner did not disassociate from the shell.Replacement elevated type liner and higher offset femoral ball head were implanted, and surgery was completed as normal.Device history records (dhr) of pe liner and other components were reviewed, and determined that all were manufactured to specification.A review of corentec`s customer complaint history was undertaken and did not identify any similar event, or any other event for the reported lot.Additional information has been requested, and if received, will be submitted in a follow up report upon completion of the investigation.Not returned to manufacturer.
Event or Problem Description
It was reported that patient had revision hip surgery due to continued hip instability following dislocation, and subsequent reduction.

• Brand Name: BENCOX PE LINER 36/44
• Common Device Name: ACETABULAR PE LINER
• Manufacturer (Section D): CORENTEC CO., LTD.; 12, yeongsanhong 1-gil; ipjang-myeon, seobuk-gu; cheonan-si, chungcheongnam-do 31056 ; KS 31056
• MDR Report Key: 5744217
• Report Number: 3009106092-2016-00002
• Device Sequence Number: 16199457
• Product Code: LPH
• UDI-Device Identifier: 08806373830372
• UDI-Public: 08806373830372
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2016

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: 12/28/2020
• Device Model Number: 01.02.643
• Device Catalogue Number: 01.02.643
• Device Lot Number: 11AFAB21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2016
• Initial Report FDA Received Date: 06/23/2016
• 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: BENCOX HYBRID CUP (CAT NO. 01.02.064)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR