MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 BI MENTUM PFRK PE LINER 28 47; BI MENTUM LINER

Catalog Number	DS10014728
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erythema (1840); Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Osteolysis (2377); Fluid Discharge (2686); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: lawyer h6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Litigation records alleges the newly implanted cobalt/chromium articul/eze head was connected to the index titanium trunion/stem and continued to generate toxic metal ions from the mixed metal modular connection.Doi: (b)(6) 2021 left hip.
Event or Problem Description
Medical records (b)(4) were reviewed by clinician.On (b)(6) 2023, the patient had a left hip aspirate for lab testing.The patient was reported to have left hip pain.The patient reports that their hip is not puffy.Chromium was noted to be 11.7 ng/ml and cobalt 14.4 ng/ml.On (b)(6) 2024 the patient was reported to have a left total hip arthroplasty removal of cup and stem and left hip insertion of antibiotic cement spacer.The findings included left hip metallosis with black/brown debris and purulent material under the liner.It was noted that the femoral stem was well fixed and an extended trochanteric osteotomy was needed for removal and it took 2 hours.During the procedure, the surgeon observed proximal osteolysis.Two dall miles cables were placed around proximal femur to reduce the eto fragments to the spacer.The pathology records report the depuy products removed.Medical/surgical notes had discrepancies in the side of the operation, with part of the surgical note stating that the surgery was on the right side and part of the same surgery notes stating that it was the left.There was zero mention of it being bilateral.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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.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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5, b7.Corrected: d4 (primary udi number).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records received: patient was revised due to metallosis who underwent revision surgery in the past with persistent elevated metal levels presenting with recurrent severe hip pain.Metal levels were persistently high when drawn at our lab with positive aspirate and mildly elevated esr.With possible infection.Right total hip arthroplasty removal of cup and stem.Right hip insertion of antibiotic cement spacer.Update (b)(6) 2024.On (b)(6) 2024 the patient was reported to have a left total hip arthroplasty removal of cup and stem and left hip insertion of antibiotic cement spacer.The findings included left hip.During the procedure, the surgeon observed proximal osteolysis.Two dall miles cables were placed around proximal femur to reduce the eto fragments to the spacer.Competitor products placed during this procedure.On (b)(6) 2024, the patient presented to er with left hip pain, nausea, vomiting, subjective fevers, and difficulty ambulating and was found to have bilateral pulmonary emboli and sepsis suspected 2/2 l hip prosthetic joint infection.On (b)(6) 2024 medical records presented (b)(6) 2024 left hip removal of antibiotic spacer and insertion of left total hip she will f/u with ortho with plan for 2-stage arthroplasty.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: although distributed by medtech orthopaedics 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 medtech orthopaedics 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: problem described is related to metal ions.The only supplier product concerned by the event is plastic (polyethylene), therefore, the supplier product is not concerned by the event.In conclusion, the complaint is inadmissible.As part of medtech orthopaedics 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 history records (dhr) were reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.

• Brand Name: BI MENTUM PFRK PE LINER 28 47
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 18912579
• Report Number: 1818910-2024-150004
• Device Sequence Number: 6826936
• Product Code: LZO
• UDI-Device Identifier: 03662200015641
• UDI-Public: (01)03662200015641(17)240630(10)1906146A
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/08/2024

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: 06/30/2024
• Device Catalogue Number: DS10014728
• Device Lot Number: 1906146A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/29/2024
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 03/29/2024; 05/20/2024; 08/12/2024; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• 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: ARTICUL/EZE BALL 28 +15.5 WH; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE DM LINER 54_47; PINNACLE SECTOR II CUP 54MM; SUMMIT POR TAPER SZ6 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White