MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 28 47; ACETABULAR LINER

Catalog Number	DS10014728
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
A depuy synthes implant was revised and reviewed for analysis reason for revision: instability & pain.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :although distributed by medtech orthopedics 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 orthopedics 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: after three reminders, no further information was provided to supplier.Documentary review: review of the manufacturing file for bi-mentum pe liner 28/47: production: 100 units of batch of 125616007 were manufactured on 25/10/2021.Dimensional and roughness controls comply with supplier specifications.The manufacturing file was checked for conformity by the release department on 10/28/2021.Technical investigation: in the absence of the device, it was not possible to conduct a technical investigation.The manufacturing data comply with supplier specifications.No additional information has been provided to identify the cause of the "pain - instability" or to demonstrate whether the supplier implant was the source of the event.Conclusion: consequently, supplier does not have sufficient information to determine the cause of the "pain - instability".The cause of the revision could neither be demonstrated nor determined.As part of medtech orthopedics 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.

• Brand Name: BI MENTUM PFRK PE LINER 28 47
• Common Device Name: ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 18978412
• Report Number: 1818910-2024-150006
• Device Sequence Number: 6035961
• Product Code: LPH
• UDI-Device Identifier: 03662200015641
• UDI-Public: 03662200015641
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024
• Report Date (Section F): 03/26/2024

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: 09/30/2026
• Device Catalogue Number: DS10014728
• Device Lot Number: 2103645A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/10/2025
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BI-MENTUM HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/26/2024