MAUDE Adverse Event Report: SERF BI MENTUM PFRK CEM CUP 51

Catalog Number	DS4901151
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was revised due to pain.Doi- unknown.Dor- (b)(6) 2025.Affected side- right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- no device associated with this report was received for examination.Although distributed by depuy synthes joint reconstruction, the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the depuy synthes customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable device history lot- the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.H11 additional narrative: added: d10 (concomitant), h5, h8.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: although distributed by depuy synthes joint reconstruction, the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the depuy synthes customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.The following investigation was provided by the supplier legal manufacturer: an event regarding pain (revision) involving a bi-mentum cemented cup 51 was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.As part of depuy synthes quality process all devices are manufactured, inspected, and released to approved specifications.No further investigation with regard to this complaint is required.The supplier will continue to monitor for trends.Device history lot: the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: BI MENTUM PFRK CEM CUP 51
• Common Device Name: PFRK CEM CUP
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 23606221
• Report Number: 1818910-2025-150021
• Device Sequence Number: 9444875
• Product Code: LPH
• UDI-Device Identifier: 03662200015429
• UDI-Public: (01)03662200015429
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2026
• Report Date (Section F): 11/20/2025

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: DS4901151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/09/2026
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/22/2025; 01/13/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BI MENTUM ALTRX LNR 51 28; PROSTALAC RT 150 STEM SZ3; UNK HIP FEMORAL HEAD CERAMIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 11/20/2025