MAUDE Adverse Event Report: CORENTEC CO.,LTD. BENCOX TOTAL HIP SYSTEM; METAL HEAD

Model Number	01.02.405
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The issue was that the 28m label was attached to the metal hard size 28s shipped to the dealership.As a result of confirmation, both products were confirmed to have been implanted into the patient's body.But there were no separate customer complaints from patients or specialists, and corentec discovered this problem first.
Additional Manufacturer Narrative
2ea metal heads shipped to the u.S.Were labeled 28s, but the actual product was packaged in a size of 28m.In order to determine the cause, we tracked it based on the lot number and found that the products of 2ea in size 28m and size 28s were packaged on the same date.Corentec shall retrieve the product from a hospital, surgeon, patient or other place of sale to ensure appropriate action is taken in accordance with customer complaint management standard (crsi-07-14) and medical device reporting standard (crsi-07-13).To this end, we tracked 2ea products shipped to the united states.After tracking the use of the products, both products were found to have been used by patients.However, no complaints were received by corentec in using this product.The total quantity manufactured for lot: 2bbbmle9 found is 2ea, and all 2ea quantities have been tracked.No complaints have yet been made to corentec regarding 2ea's products that have already been used on patients, but corentec will accept mdrs to report this issue as a preemptive response and try to find essential information about mdrs.To address this issue, corrective actions will be issued so that root cause analysis can be found.

• Brand Name: BENCOX TOTAL HIP SYSTEM
• Common Device Name: METAL HEAD
• Manufacturer (Section D): CORENTEC CO.,LTD.; 12, yeongsanhong 1-gil; ipjang-myeon, seobuk-gu; cheonan-si, chungcheongnam-do 31056
• Manufacturer (Section G): CORENTEC CO.,LTD.; 12, yeongsanhong 1-gil; seobuk-gu, ipjang-myeon; cheonan-si, chungcheongnam-do 31056 ; KS 31056
• Manufacturer Contact: mr. lee ; 12, yeongsanghong 1-gil; seobuk-gu, ipjang-myeon; cheonan-si, chungcheongnam-do 31056 ; KS 31056
• MDR Report Key: 18107994
• Report Number: 3009106092-2023-00002
• Device Sequence Number: 6874804
• Product Code: LPH
• UDI-Device Identifier: 08806373830600
• UDI-Public: 8806373830600
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/09/2023

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 Model Number: 01.02.405
• Device Lot Number: 2BBBMLE9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose