MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION RM52260045 DS10014522 BI MENTUM RK PE LINER 22 45; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	UNK_JSE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4): (b)(6) the patient was revised due to dislocation.No surgical delay.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: RM52260045 DS10014522 BI MENTUM RK PE LINER 22 45
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines 69150 ; FR 69150
• Manufacturer (Section G): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines 69150 ; FR 69150
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 21226028
• Report Number: 3008668801-2025-00041
• Device Sequence Number: 15322286
• Product Code: MEH
• UDI-Device Identifier: 03662200015511
• UDI-Public: 03662200015511
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: UNK_JSE
• Device Lot Number: 2009398A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown