MAUDE Adverse Event Report: SOC ETUDES RECERCHES FABRICATION BI MENTUM PFRK CEM CUP 51

Catalog Number	DS4901151
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision of a reclaim bimentum was done.The reason for revision was due to instability.The patient previously had a girdlestone procedure, and was like that for a number of years.The surgeon noted that during the primary surgery they were stable on the table with a 24x95 reclaim body, but their adductor muscles were gone, and surrounding tissues were dysfunctional.At some point after surgery patient moved into a position (which the surgeon advised not to) and they dislocated.The reclaim body, bimentum poly and 28+8.5 ceramic head were removed.Cup was retained.Then a longer body, new poly and 28+12 head were implanted.The surgeon said that the patient's soft tissues are very poor, and they have no adductor muscles.No previous revision had been done for dislocations.There was no surgical delay.Affected side: right side.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.H11 corrected data: b1, b5, h1, h6: the initial complaint was reviewed and found to be not reportable.The previously reported event was determined to have occurred in new zealand and therefore does not meeting reporting requirements as an importer.This does not meet the definition of a complaint and therefore please disregard any further reports on 1818910-2025-150001.
Event or Problem Description
Upon further review, the previously reported event was determined to have occurred in new zealand and therefore does not meeting reporting requirements as an importer.This does not meet the definition of a complaint and therefore please disregard any further reports on 1818910-2025-150001.

• Brand Name: BI MENTUM PFRK CEM CUP 51
• Common Device Name: PFRK CEM CUP
• Manufacturer (Section D): SOC ETUDES RECERCHES FABRICATION; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 21696083
• Report Number: 1818910-2025-150001
• Device Sequence Number: 18406809
• Product Code: LPH
• UDI-Device Identifier: 03662200015429
• UDI-Public: (01)03662200015429(17)290831(10)2401765A
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025
• Report Date (Section F): 03/26/2025

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 Catalogue Number: DS4901151
• Device Lot Number: 2401765A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2025
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2024
• 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 Sex: Unknown
• Date Report Sent to FDA: 03/26/2025