MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION BI-MENTUM PRESSFIT CUP 51; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	DS45320151
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In the absence of information allowing traceability of defective products, the document review cannot be carried out.The pre/post-revision x-rays show a replacement of the implants and in particular an anchoring of the acetabulum with hook and screw during the revision, confirming the revision.The patient occured a fracture of the calcar as well as a positioning of the acetabulum "too medial" with a protruding hole in the small pelvis.The understanding that can be made of this is a defect in the positioning of the acetabulum.However, the information provided is insufficient to confirm or refute this hypothesis.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

• Brand Name: BI-MENTUM PRESSFIT CUP 51
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: jean-denys marechal ; 85 avenue des bruyeres; 69150 decines-charpieu; decines 69150 ; FR 69150 ; 472056010
• MDR Report Key: 22089030
• Report Number: 3008668801-2025-00117
• Device Sequence Number: 15190412
• Product Code: LZO
• UDI-Device Identifier: 03662200014996
• UDI-Public: 03662200014996
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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: DS45320151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female