MAUDE Adverse Event Report: SERF 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	Joint Dislocation (2374)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Clinical adverse event received for dislocation.Event is serious and is considered mild.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2016.Date of event: (b)(6) 2022.(left hip).Treatment: closed reduction/manipulation.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
(b)(6) 2022: the patient undergoes a closed reduction under general anesthesia with success.The operative notes do not provide any additional details not already captured on this pc.The patient has a history of septic hip with gram-positive cocci as well as a fungal infection as well as anterior and posterior dislocations.Per the joint registry, these failures are noted to be in affiliation to competitor products.She also has trochanteric escape due to a competitor stem.On (b)(6) 2021, the patient underwent a revision of a competitor stem and head as well as a polyethylene bimentum liner due to recurrent instability (already captured on (b)(4).The cerclage wires (noted to be synthes products per joint registry) were loose and creating metallosis so they were removed.The trochanter is completely non-united.The surgeon felt ¿quite a bit of combined version between the stem and the cup so he plans to decrease it by changing the proximal body on the competitor stem.¿ he later states the cup appeared to ¿be reasonably well positioned¿ so the cup will not be coded for mispositioning.

• Brand Name: BI MENTUM PFRK PE LINER 22 43
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 15587738
• Report Number: 1818910-2022-50043
• Device Sequence Number: 2762307
• Product Code: LPH
• UDI-Device Identifier: 03662200015504
• UDI-Public: 03662200015504
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/12/2022
• Report Date (Section F): 10/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: BI-MENTUM PE LINER 22,2 / 43
• Device Catalogue Number: DS10014322
• Device Lot Number: 1906131A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2019
• 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 43; BI MENTUM PFRK PE LINER 22 43; COMPETITOR HEAD; COMPETITOR STEM; DEPUY/CMW 2G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 10/12/2022