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

Catalog Number UNK KNEE STEM SIGMA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 02/17/2020

Event Type  Injury  

Event Description

Date of receipt of complaint : 9 april 2024.On (b)(6) 2020 patient underwent a first stage of lt tkr revision 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 it was after 9 prior infection revisions).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.Less than 2 years after implantation patient complained of heavy sensation on the lt leg and instability of left knee.Upon examination on (b)(6) 2023 - over flexion of 20 degrees and lack of stability ml.On imaging: impression of loosening of the two components.In the tibia observed migration of the implant and the stem tunnels it way through the lateral cortex.A radiolucent line around the femoral component in the metaphysical part.Puncture was taken.On (b)(6) 2023 follow up visit - infectious process 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 (b)(4) captured for the 2nd revision): patient underwent a lt tkr revision.In a follow-up visit on (b)(6) 2023 ¿ post revision on the background of aseptic loosening and fracture of the implant.Good stability.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3 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: 19172933
• MDR Text Key: 340927075
• Report Number: 1818910-2024-08947
• 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,Followup
• Report Date: 04/24/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE STEM SIGMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/02/2024
• 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 STEM SIGMA.; UNK KNEE STEM SIGMA.; UNK KNEE TIBIAL TRAY SIGMA (RP) MBT.; UNKNOWN KNEE FEMORAL SLEEVE.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR