MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION RM52260041 DS10014122 BI MENTUM RK PE LINER 22 41; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	UNK_JSE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
(b)(4): (b)(6): this pi is covering infection.Notes: from (b)(4) aei note (b)(6) medical records (b)(6) 2023 pertaining to non-mom construct was reviewed by clinician.On (b)(6) 2022, the patient had a right total hip arthroplasty to address osteoarthritis.Depuy products were implanted.Part/lot page 6 of 632 (b)(4).Medical records (b)(6) 2023.Pdf).On (b)(6) 2022, the patient had a right total knee arthroplasty (page 615 of 632 no specifics).On (b)(6) 2023, the patient had a right hip revision of acetabular liner and femoral head to address catastrophic failure.Indications for surgery included patient having pain, multiple falls, and a radiograph demonstrated femoral head high in the cup, which is consistent with catastrophic failure or liner dislocation (disassociation).During the procedure, the surgeon observed that the liner had come loose and had rotated into an inferior position resulting in articulation and impingement of the ceramic head.The femoral head had a significant stripe wear consistent with metal wear.The cup and stem were retained.Depuy pinnacle dual mobility liner, depuy bi-mentum pe liner and depuy articul/eze femoral head were implanted during this procedure.(surgery page 233 of 632 (b)(4) medical records (b)(6) 2023.Pdf) (part/lot page 375 of 832 (b)(4) medical records (b)(6) 2023.Pdf) (b)(4) on (b)(6) 2023 medical records note the patient is 11 weeks post op and feel pain within the gluteus maximus muscle and is worried about dislocating the hip.Surgeon noted long standing pain in right hip despite treatment and normal imaging/physical exam.(this is only 11 weeks post op and pain is an expected outcome while healing post operatively.No new pc required at this time) (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.(new pc required.) past medical history included: hypertension, hld, depression, anxiety, arthritis, ptsd.Event description: medical records (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: 20 jul 2023 right hip.

• Brand Name: RM52260041 DS10014122 BI MENTUM RK PE LINER 22 41
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines 69150 ; FR 69150
• Manufacturer (Section G): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines 69150 ; FR 69150
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 21226001
• Report Number: 3008668801-2025-00044
• Device Sequence Number: 12835276
• Product Code: MEH
• UDI-Device Identifier: 03662200015498
• UDI-Public: 03662200015498
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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: 09/30/2025
• Device Catalogue Number: UNK_JSE
• Device Lot Number: 2002684A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown