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

Catalog Number DS10014122

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

Patient Problems Fatigue (1849); Hematoma (1884); Inflammation (1932); Pain (1994); Seroma (2069); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)

Event Type  Injury  

Event 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.

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.

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.

• Brand Name: BI MENTUM PFRK PE LINER 22 41
• Type of Device: HIP LINER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 18442516
• MDR Text Key: 331863254
• Report Number: 1818910-2024-150001
• Device Sequence Number: 1
• Product Code: LPH
• 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: 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
• Device Operator: Health Professional
• 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: 02/15/2024
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• 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: ACTIS COLLARED STD SIZE 2.; ARTICUL/EZE BALL 22.225+7 NK.; PINNACLE DM LINER 48_41.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female