MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE STEM SIGMA

Catalog Number UNK KNEE STEM SIGMA

Device Problem Migration (4003)

Patient Problems Loss of Range of Motion (2032); Ambulation Difficulties (2544); Joint Laxity (4526); Physical Asymmetry (4573)

Event Date 11/05/2023

Event Type  Injury  

Event Description

J-c health care ltd.Received on 9 april 2024 a demand letter dated (b)(6) 2024 pertaining to a total knee replacement with sigma implant.According to the demand letter, back in 2019 patient underwent a lt tkr in russia (unknown implant) and suffered from infection.Thereafter patent underwent several infection revisions (also in russia) including removal of tibial implant and insertion of spacer, that did not solve the infection.During february-july 2020 patient was treated at sheba medical center in israel.On (b)(6) 2020 (b)(4) captured for the 1st revision) patient underwent a first stage of lt tkr revision at sheba medical center due to "infection and inflammatory reaction due to internal joint prosthesis (left)" during which her implants were removed and an antibiotic spacer was implanted.Thereafter patient was placed in plaster cast/brace and knee fixation and received a long term systemic antibiotic treatment under laboratory monitoring.After 6 weeks of antibiotic treatment with vancomycin and laboratory monitoring for additional 2 months, it was found that there was no inflammation of the infection following cessation of the antibiotics and the knee was "quiet", the second stage of the revision was carried out (b)(6) 2020 (noting in the medical records it was after 9 infection revisions) during which a hinge prosthesis from the depuy sigma knee system was implanted.The procedure underwent intact with no special complications.On (b)(6) 2020 follow-up visit - crp levels reduced to 12 without antibiotics, imaging ¿ implant in good position with ranges of flex and bend as expected in her condition.Patient returned to russia but less than 2 years after surgery claimed that had began to feel a heavy sensation in left leg and thereafter serious deterioration in patient's condition and instability of left knee appeared ¿ it began to "escape backwards" and leg was also allegedly shortened by ~5cm.Patient also claims to have experienced difficulties in walking and functioning and returned to israel to be checked at sheba mc.Upon examination on 25 october 2023 the surgeon found over extension of 20 degrees and lack of stability ml.On imaging: impression of loosening of the two components.In the tibia it can be observed that there is a migration of the implant and the stem tunnels it way through the lateral cortex.There is also a radiolucent line around the femoral component in the metaphysical part.Puncture was taken.On 31 october 2023 follow up visit - following imaging and after infectious process was overruled, it was decided to carry out a lt tkr revision on the background of suspected fracture of the liner and the axis system of the implant and suspected loosening of the components.On (b)(6) 2023 patient underwent a lt tkr revision with a depuy replacement implant.In a follow-up visit on 21 november 2023 ¿ post revision on the background of aseptic loosening and fracture of the implant.Good stability.To be noted: the claims raised in the demand letter relate to the alleged fractured and loosened implant that was implanted on (b)(6) 2020.No surgery reports were provided.No product stickers were provided.No imaging test results were provided with the demand letter.

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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.

• Brand Name: UNK KNEE STEM SIGMA
• Type of Device: KNEE STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19173478
• MDR Text Key: 340936021
• Report Number: 1818910-2024-08966
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE STEM SIGMA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: LPS UNIV TIB HIN INS XSM 18MM; UNK KNEE FEMORAL SIGMA; UNK KNEE FEMORAL SLEEVE; UNK KNEE STEM SIGMA; UNK KNEE STEM SIGMA; UNK KNEE TIBIAL TRAY SIGMA (RP) MBT
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR