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

Catalog Number DS10014728

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems 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)

Event Date 02/22/2024

Event Type  Injury  

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
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> 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
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> 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 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 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.

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.

• Brand Name: BI MENTUM PFRK PE LINER 28 47
• Type of Device: BI MENTUM LINER
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 18912579
• MDR Text Key: 337760925
• Report Number: 1818910-2024-150004
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03662200015641
• UDI-Public: 03662200015641
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 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.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White