MAUDE Adverse Event Report: SERF BI MENTUM PFRK CEM CUP 47; BI MENTUM CUP

Model Number	BI-MENTUM Cemented Cup 47
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).F10 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: although distributed by depuy synthes joint reconstruction, the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the depuy synthes customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.The products were not returned, no product for investigation can be performed.No x ray has been provided, no information.All batches are released in compliance with supplier specifications.Supplier has no evidence to determine the cause of the complaint.Conclusion: revision leading to implant replacement can be caused by several factors that cannot be demonstrated due to lack of information.Supplier devices involvement is unlikely in these cases.The cause of the problem cannot be confirmed.
Event or Problem Description
Patient was revised due to pain.There was no surgical delay.Doi: (b)(6) 2023.Dor: (b)(6) 2023.Affected side: left hip.

• Brand Name: BI MENTUM PFRK CEM CUP 47
• Common Device Name: BI MENTUM CUP
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 16831257
• Report Number: 1818910-2023-150018
• Device Sequence Number: 13929891
• Product Code: LPH
• UDI-Device Identifier: 03662200015405
• UDI-Public: 03662200015405
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2023
• Report Date (Section F): 04/28/2023

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: BI-MENTUM Cemented Cup 47
• Device Catalogue Number: DS4901147
• Device Lot Number: 2206204A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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: BI MENTUM PFRK CEM CUP 47.; BI MENTUM PFRK PE LINER 28 47.; DLT TS CER HD 12/14 28MM +8.5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/28/2023