MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION BI-MENTUM PE LINER 22.2/43; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	DS10014322
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
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
Patient was continuing to dislocate.The liner was converted from a dual mobility to a constrained liner.Right hip.
Additional Manufacturer Narrative
Manufacturer entity d3 corrected to s.E.R.F societe detudes recherche fabrication.
Event or Problem Description
Patient was continuing to dislocate.The liner was converted from a dual mobility to a constrained liner.Right hip.
Event or Problem Description
Patient was continuing to dislocate.The liner was converted from a dual mobility to a constrained liner.Right hip.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation (leading to revision) involving a bi mentum pe liner 22/43 was reported.Conclusions: the reported device is an serf product.Written acknowledgement from serf that an investigation has been initiated at the site was received and has been attached within the communication log."technical investigation: the technical investigation cannot be carried out because the product has not been returned.Documentary investigation: (b)(4) units manufactured.No non-compliance observed on this batch.(b)(4) units marketed by serf in december 2020.No other complaints have been recorded on this batch.Root cause hypothesis.Device compliance when placed on the market.In the absence of further information, the most likely cause cannot be determined." corrective action/preventive action: no action is required by stryker at this time as the investigation for this event is performed by serf.

• Brand Name: BI-MENTUM PE LINER 22.2/43
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: jean-denys marechal ; 85 avenue des bruyeres; 69150 decines-charpieu; decines, NJ 69150 ; FR 69150 ; 2018315000
• MDR Report Key: 21100501
• Report Number: 3008668801-2025-00001
• Device Sequence Number: 8818515
• Product Code: LZO
• UDI-Device Identifier: 03662200015504
• UDI-Public: 03662200015504
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K181744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2026

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: 11/30/2025
• Device Catalogue Number: DS10014322
• Device Lot Number: 2009413A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/24/2025; 01/28/2026
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/24/2025; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female