MAUDE Adverse Event Report: CORENTEC CO., LTD. BENCOX TOTAL HIP SYSTEM INSTRUMENT HEAD TRIAL; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	HA.02I.0361
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case was delayed due to trial head becoming stuck, but trial head was ultimately successfully removed.Trunnion of stem implant could have been potentially scratched.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, it's hard to define the root cause currently and monitoring the trends is required.Once any supplemental information is found which would change any information or conclusions, additional information will be filed accordingly.
Event or Problem Description
A portion of the metal locking ring inside the trial head was protruding out which caused the trial to become stuck on the stem trunnion.

• Brand Name: BENCOX TOTAL HIP SYSTEM INSTRUMENT HEAD TRIAL
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): CORENTEC CO., LTD.; 12, yeongsanhong 1-gil; ipjang-myeon, seobuk-gu; cheonan-si, chungcheongnam-do 31056 ; KS 31056
• MDR Report Key: 7863458
• Report Number: 3009106092-2018-00002
• Device Sequence Number: 1911361
• Product Code: KWY
• UDI-Device Identifier: 08806373879043
• UDI-Public: (01)08806373879043(11)170214(10)30AGAKJ2001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HA.02I.0361
• Device Catalogue Number: HA.02I.0361
• Device Lot Number: 30AGAKJ2001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2018
• 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
• Patient Age: 53 YR