MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION GE007-55 TRIAL CUP 55; TEMPLATE FOR CLINICAL USE

Catalog Number	RA90390955
Medical Device Problem Codes	Fracture (1260); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a total hip arthroplasty procedure, the trial cup was stuck.Trial cup was broken trying to remove it.The procedure was successfully performed using an other available trial cup.
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.
Additional Manufacturer Narrative
Reported event: an event regarding a crack/fracture involving a ge007-55 trial cup 55 was reported.Conclusions: based on the provided information it has been determined that this event is associated with an off-label application.It was reported that the instrument "white tip of the femoral impactor ref: (b)(4)" is used with the ge007-55 trial cup 55.This instrument is not a serf reference.Non-serf instruments, not intended for use with the trial cup, appear to have been used during the removal attempts, which contributed to the observed damage.It is the responsibility of the surgeon to follow the surgical protocol and use the appropriate surgical technique.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
Event or Problem Description
No new information.

• Brand Name: GE007-55 TRIAL CUP 55
• Common Device Name: TEMPLATE FOR CLINICAL USE
• 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: 23987771
• Report Number: 3008668801-2026-00001
• Device Sequence Number: 4630696
• Product Code: HWT
• UDI-Device Identifier: 03662200012671
• UDI-Public: 03662200012671
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RA90390955
• Device Lot Number: 122654006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown