MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION BI-MENTUM CEMENTED CUP 61 RM52240061; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	UNK_JSE
Medical Device Problem Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant was revised and reviewed for analysis.Reason for revision: revision due to dislocation and cup loosening.The non-articular surface of the acetabular cup shows, no cement remaining.Cement manufacturer is unknown.
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.
Event or Problem Description
Implant was revised and reviewed for analysis.Reason for revision: revision due to dislocation and cup loosening.The non-articular surface of the acetabular cup shows, no cement remaining.Cement manufacturer is unknown.
Additional Manufacturer Narrative
Manufacturer entity d3 corrected to s.E.R.F societe detudes recherche fabrication.An event regarding dislocation and loosening involving an unknown bi-mentum shell was reported.Conclusions: the reported device is an serf product.Written acknowledgement from serf that an investigation has been initiated under ref # (b)(4).

• Brand Name: BI-MENTUM CEMENTED CUP 61 RM52240061
• 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 NJ 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20784285
• Report Number: 3008668801-2024-00005
• Device Sequence Number: 8948951
• Product Code: LZO
• UDI-Device Identifier: 03662200015474
• UDI-Public: 03662200015474
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K181744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: 05/31/2025
• Device Catalogue Number: UNK_JSE
• Device Lot Number: 2002680A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2020
• 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