MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 28 53; BIMENTUM LINER

Model Number	BI-MENTUM PE LINER 28 / 53
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Fatigue (1849); Pain (1994); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
On (b)(6) 2023, the patient had a revision left hip with removal of acetabular cup, screws x5, and placement of competitor cup and screws x4, along with depuy femoral head.Prior to surgery, the patient was experiencing instability.During the procedure, the surgeon observed weakness of the gluteus maximus muscle.The dual mobility head was revised, along with the liner.Doi: (b)(6) 2022; dor: (b)(6) 2023; left hip.
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 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 supplier 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.Supplier devices involvement is unlikely in these cases.The cause of the problem cannot be confirmed.The supplier will continue to monitor for trends.Device history lot: supplier has not provided details for dhr.
Event or Problem Description
Medical records were received: doe: (b)(6) 2022: patient presents with pain and feelings of instability in her left hip.X rays identify a well-fixed and stable tha.Patient is treated with physical therapy and oral medication.Doe: (b)(6) 2022: patient received a closed reduction of the left hip to treat a dislocation after a slip and fall while feeding her cat.The procedure was completed without complications.The patient is prescribed additional physical therapy.Patient continued to experience pain and instability after physical therapy and on (b)(6) 2023, the patient was referred for revision to treat the instability and pain secondary to dislocation of the left hip following a fall.(b)(6) 2023: patient received a left hip revision to treat instability and pain secondary to a dislocation after a fall.The femoral stem was stable and retained.The cup, screws, and dual mobility head/liner were revised and replaced with competitor products.The procedure was completed without complications.The dislocation treated with closed reduction and the revision to treat instability are continuations of the same event.Doi: (b)(6) 2023 doe: (b)(6) 2022 dor: (b)(6) 2023 left hip.
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: on (b)(6) 2023, answer was sent to the supplier: ¿no information was received from sales representative after three follow ups.So, please proceed without the sample.¿ the products were not returned, no product for investigation can be performed.All batches are released in compliance with the supplier specifications.X-rays have been provided.Based on the x-rays provided, no implant problems have been identified, and the head centers between the cup and the femoral head overlap perfectly.However, the x-ray may suggest a surgical issue.The lesser trochanter (insertion of the iliopsoas muscle) seems to be detached from the proximal part of the femur, and the greater trochanter is virtually non-existent.The hip may be instable in such a situation.In conclusion, the supplier implant is not affected by revision.Conclusion: the cause identified is probably not linked with the device.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 supplier did not provide the dhr review results.

• Brand Name: BI MENTUM PFRK PE LINER 28 53
• Common Device Name: BIMENTUM LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 17323975
• Report Number: 1818910-2023-150027
• Device Sequence Number: 20211130
• Product Code: LZO
• UDI-Device Identifier: 03662200015672
• UDI-Public: 03662200015672
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 07/14/2023
• Report Date (Section F): 07/14/2023

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 Model Number: BI-MENTUM PE LINER 28 / 53
• Device Catalogue Number: DS10015328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/24/2024
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 07/26/2023; 05/26/2024
• 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: DELTA CER HEAD 12/14 28MM +1.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX50MM; PINNACLE DM LINER 62_53; UNKNOWN HIP ACETABULAR CUP; UNKNOWN SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/14/2023