MAUDE Adverse Event Report: SOC ETUDES RECHERCHES FABRICATION BI MENTUM PFRK PE LINER 28 61; BI MENTUM LINER

Model Number	BI-MENTUM PE LINER 28 / 61
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).The approximate age of device is the length of time the device was implanted in the patient.
Event or Problem Description
It was reported that patient dislocated his hip.Revision surgery was needed to reduce the hip as well as go up on head size in order to gain more stability.Doi: (b)(6) 2020; dor: (b)(6) 2020; affected side: unknown.

• Brand Name: BI MENTUM PFRK PE LINER 28 61
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): SOC ETUDES RECHERCHES FABRICATION; 85 avenue des bruyres; dcines-charpieu 69150 ; FR 69150
• MDR Report Key: 10853469
• Report Number: 1818910-2020-50006
• Device Sequence Number: 17213979
• Product Code: LZO
• UDI-Device Identifier: 03662200015719
• UDI-Public: 03662200015719
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020
• Report Date (Section F): 11/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BI-MENTUM PE LINER 28 / 61
• Device Catalogue Number: DS10016128
• Device Lot Number: 1907017A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/29/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 11/22/2020
• 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 CUP; DELTA CER HEAD 12/14 28MM +1.5
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 11/17/2020