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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The approximate age of device captured in is the length of time the device was implanted in the patient.
Event or Problem Description
It was reported that patient had very high hip center on primary hip performed in (b)(6) of 2019 and at that time patient was left short.Today, a longer stem was placed to get the patient back closer to equal leg lengths.Doi: (b)(6) 2019.Dor: (b)(6) 2020.Right hip.

• 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 bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 10164295
• Report Number: 1818910-2020-50003
• Device Sequence Number: 3045358
• Product Code: LZO
• UDI-Device Identifier: 03662200015719
• UDI-Public: 03662200015719
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2020
• Report Date (Section F): 06/17/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: BI-MENTUM PE Liner 28 / 61
• Device Catalogue Number: DS10016128
• Device Lot Number: 1904328A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/21/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 66
• Date Report Sent to FDA: 06/17/2020