MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL STEM

Catalog Number UNK KNEE FEMORAL STEM

Device Problems Corroded (1131); Degraded (1153); Fracture (1260); Naturally Worn (2988)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled, "failure and fatigue fracture at the femoral-stem metaphyseal sleeve junction in modular knee prosthesis" published by the journal of bone and joint surgery (2018) was reviewed.The article is a case report of a (b)(6) man who received a primary right total knee arthroplasty with a cemented lcs (depuy) implant in 2012.At 10 months post op he sustained an overuse injury while using his right leg to break wood.Radiographs revealed a separation of the femoral component from the distal anterior femoral cortex (refer to figure 1a).He underwent a 2 stage revision in august 2013 with lcs revision knee system with sleeve and stem.November 2015 during a routine follow up progressive osteolysis was noted around the right distal femoral stem.Ct revealed a new area of osteolysis at bone-prosthesis interface of the lateral aspect of the femoral sleeve and uneven wear of the stem that was in contact with the sleeve (refer to figure 2a).Patient remained asymptomatic until november 2016 and reported pain in right knee.Radiographs demonstrated "bending of the stem on the sleeve" and he continued to amnbulate with discomfort for additional 6 months.Radiographs present a possible early fracture and pre-revision ct display a clear fracture of the implant at the stem-sleeve junction with evident osteolysis around the meetaphyseal sleeve (refer to figure 2b).In 2017, 3 years and 9 months after initial revision, repeat revision was performed.Intraoperative findings were the femoral component and sleeve were grossly loose and a fracture through the stem implant at the stem-sleev interface.Figures 5a and 5b make note of gross crevice corrosion pits and completely worn threates of the lateral aspect of the stem.A new lcs revision implant was placed with long femoral stem and sleeve and patient did well and was symptom free at 6 month follow up.Cement manufacturer unknown and patella resurfacing not discussed in article.No indication that tibial components were revised but assumed that insert would be exchanged at each revision.Depuy products: lcs knee system primary and revision adverse events: revision for femoral component loosening (interface not specified) pain re-revision for femoral stem fracture (noted to have corrosion and fretting) osteolysis anatomically located on lateral femoral sleeve to bone interface (no mention of insert wear or poly debris) intraoperative findings of loose femoral component intraoperative findings of loose femoral sleeve.

• Brand Name: UNKNOWN KNEE FEMORAL STEM
• Type of Device: KNEE FEMORAL 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: kara ditty-bovard ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 9621464
• MDR Text Key: 185299519
• Report Number: 1818910-2020-02597
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 02/28/2020
• 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
• Patient Outcome(s): Required Intervention