MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 43; BI MENTUM LINER

Model Number	BI-MENTUM PE Liner 22,2 / 43
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had i&d of hip.Liner and head exchanged.Infection was confirmed.Doi: (b)(6) 2022.Dor: (b)(6) 2022.Affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 specifications the supplier has no evidence to determine the cause of the complaint.Revision leading to implant replacement can be caused by several factors that cannot be demonstrated due to lack of information.The supplier devices involvement is unlikely in these cases.The root causes of these events remain undetermined.No further investigation with regard to this complaint is required.The supplier will continue to monitor for trends.

• Brand Name: BI MENTUM PFRK PE LINER 22 43
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 15979193
• Report Number: 1818910-2022-50049
• Device Sequence Number: 17873219
• Product Code: LPH
• UDI-Device Identifier: 03662200015504
• UDI-Public: 03662200015504
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/14/2022
• Report Date (Section F): 12/14/2022

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 PE Liner 22,2 / 43
• Device Catalogue Number: DS10014322
• Device Lot Number: 2006241A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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: ARTICUL/EZE BALL 22.225+4 NK.; BI MENTUM PFRK PE LINER 22 43.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 12/14/2022