MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 41; HIP LINER

Model Number	BI-MENTUM PE LINER 22,2 / 41
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021 an i&d was performed and dual mobility components were implanted.On (b)(6) 2021 all components were removed and an i&d was performed.A prostalac spacer was implanted to continue with antibiotic treatment for infection.This is all the info that i have to offer about the case.It was also indicated that there was loosening of the cup at the bone to implant interface.Doi: (b)(6) 2021 - dor: (b)(6) 2021 (right hip).
Event or Problem Description
Additional information was received indicating that the loosening was due to the infection.The surgery was extended due to implants removed and allowing for mold to cure.I&d stands for irrigation and debridement.
Event or Problem Description
Additional information received indicated that the loosening was from infection.This was considered to be stage two revision.Prostalic was implanted for continuum care.The case in june was an irrigation and debridement and converted to a dual mobility.Surgery time was extended to remove the implants and also to irrigate and debride the tissues and allowing for mold to cure.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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.

• Brand Name: BI MENTUM PFRK PE LINER 22 41
• Common Device Name: HIP LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 13051065
• Report Number: 1818910-2021-50051
• Device Sequence Number: 16546534
• Product Code: LZO
• UDI-Device Identifier: 03662200015498
• UDI-Public: 03662200015498
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2021
• Report Date (Section F): 12/21/2021

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 / 41
• Device Catalogue Number: DS10014122
• Device Lot Number: 2006240A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/07/2022; 01/25/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/21/2022; 01/25/2022
• 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: ACTIS COLLARED HIGH SIZE 5; ARTICUL/EZE BALL 22.225+7 NK; PINN SECTOR W/GRIPTION 48MM; UNK HIP ACETABULAR LINER METAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/21/2021