MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 41; HIP LINER IMPLANT

Catalog Number	DS10014122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hematoma (1884); Inflammation (1932); Pain (1994); Seroma (2069); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
Medical records ad (b)(6) 2023 pertaining to non mom construct was reviewed by clinician.(b)(6) 2023 mri demonstrates right hip arthroplasty, mild increased signal on fluid sensitive sequences along the femoral stem.Moderate right greater trochanteric bursitis versus hematoma/seroma.The patient also reported having weakness and pain.The impression is mild trochanteric bursitis.Iliopsoas tendinitis appears to be from prominence of the irritating psoas tendon itself.Corticosteroid injection is recommended.Doi: (b)(6) 2022 ( stem).Doi: (b)(6) 2023 (liner, head).Doe: (b)(6) 2023.Right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: lawyer.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.
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.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.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).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: the products were not returned, no product for investigation can be performed.No x ray has been provided, no information.All batches are released in compliance with serf specifications.Serf has no evidence to determine the cause of the complaint.Conclusion revision leading to implant replacement can be caused by several factors that cannot be demonstrated due to lack of information.Serf device is not involved.The cause of the problem cannot be confirmed.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 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.The supplier did not provide the dhr review results.

• Brand Name: BI MENTUM PFRK PE LINER 22 41
• Common Device Name: HIP LINER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 18442516
• Report Number: 1818910-2024-150001
• Device Sequence Number: 6883787
• Product Code: LPH
• UDI-Device Identifier: 03662200015498
• UDI-Public: 03662200015498
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: DS10014122
• Device Lot Number: 2002684A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/22/2024
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/20/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACTIS COLLARED STD SIZE 2; ARTICUL/EZE BALL 22.225+7 NK; PINNACLE DM LINER 48_41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female