MAUDE Adverse Event Report: SOC ETUDES RECHERCHES FABRICATION BI MENTUM PFRK PE LINER 28 49; BI MENTUM LINER

Model Number BI-MENTUM PE Liner 28 / 49

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 03/26/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient was revised due to infected total hip.Head and liner was exchanged for irrigation and debridement.Bimentum liner with stryker head was removed and replaced with a new construct due to the presence of infection.Doi: (b)(6) 2022, dor: (b)(6) 2022, affected side: right hip.

• Brand Name: BI MENTUM PFRK PE LINER 28 49
• Type of Device: BI MENTUM LINER
• Manufacturer (Section D): SOC ETUDES RECHERCHES FABRICATION; 85 avenue des bruyres; dcines-charpieu 69150 ; FR 69150
• MDR Report Key: 14084403
• MDR Text Key: 289087842
• Report Number: 1818910-2022-50020
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 03662200015658
• UDI-Public: 03662200015658
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2022

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
• Device Operator: Health Professional
• Device Model Number: BI-MENTUM PE Liner 28 / 49
• Device Catalogue Number: DS10014928
• Device Lot Number: 1907027A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2022
• Distributor Facility Aware Date: 03/29/2022
• Date Report to Manufacturer: 03/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2022
• Date Device Manufactured: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male