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

Device Problem Insufficient Information (3190)

Patient Problem Not Applicable (3189)

Event Date 04/16/2018

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer Contact: hyunchul koh ; yeongsanhong 1-gil; seobuk-gu, ipjang-myeon; cheonan-si, chungcheongnam-do 31056 ; KS 31056
• MDR Report Key: 7863458
• MDR Text Key: 119940204
• Report Number: 3009106092-2018-00002
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 08806373879043
• UDI-Public: (01)08806373879043(11)170214(10)30AGAKJ2001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: HA.02I.0361
• Device Catalogue Number: HA.02I.0361
• Device Lot Number: 30AGAKJ2001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR