MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ2.5 L; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	196040250
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Event or Problem Description
Subject id: (b)(6).Study no: (b)(6).Clinical adverse event received for migration; femoral and tibial loosening.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(3) 2020.Date of event: (b)(3) 2022.Date of revision: (b)(3) 2023 (left knee).Treatment: revision, femoral, tibial, and insert were revised.
Event or Problem Description
Operative note received.On (b)(6) 2023, the patient had a revision of left total knee replacement to address mechanical loosening of other internal prosthetic joint, stiffness of knee, and aseptic loosening of prosthetic knee.The indication for surgery included pain and swelling.The patient is status post a prior revision total knee replacement on (b)(6) 2020 with a constrained device.Radiographs demonstrated tibial component loosening.The surgeon observed dense fibrous tissue, adhesions and the femoral component was noted to be grossly loose.The tibial component was noted to be grossly loose.Cement was then debrided from the distal femur and proximal tibia.There was no specific interface provided.Depuy components were implanted, including a depuy mbt revision size 3 cemented rotating platform tray, mbt revision 29 mm porous metaphyseal sleeve, 115mm x16 mm universal fluted stem, depuy sigma rotating platform, tc 3 size 2.5/15mm, femur: sigma size 2.5 left cement tc 3 with 8mm distal medial and lateral augments, 4 mm posterior lateral augment, 5 degree femoral adapter, 31 mm universal bully porous-coated femoral sleeve, 75 mm x 14 mm universal fluted stem and neutral adapter bolt.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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.If additional information is made available, 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.
Event or Problem Description
Medical records received.The indications, for surgery included pain and swelling.
Additional Manufacturer Narrative
Product complaint (b)(4).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, that 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.Added: b5, h6 health effect: clinical code.

• Brand Name: SIGMA PS CEM FEM SZ2.5 L
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18363122
• Report Number: 1818910-2023-25665
• Device Sequence Number: 12784554
• Product Code: JWH
• UDI-Device Identifier: 10603295075035
• UDI-Public: 10603295075035
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2023

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 Catalogue Number: 196040250
• Device Lot Number: 9077547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 01/17/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/05/2024; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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: MBT REVISION CEM TIB TRAY SZ 3; PFC SIGMA STAB+ INS 15MM SZ3; PFC* MOD PLUS TIBIAL TRAY SZ 3; PFCSIGMA 3POST RDDOME PAT 41MM; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White