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

Catalog Number UNK KNEE FEMORAL SLEEVE

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Injury (2348); No Code Available (3191)

Event Type  Injury  

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 ¿metaphyseal sleeves in revision total knee arthroplasty: minimum seven-year follow-up study¿, written by sanjeev agarwal, et al.Published in the knee 25 (2018) 1299-1307, https://doi.Org/10.1016/j.Knee.2018.09.010, was reviewed.The purpose of the article was to report early results with the use of metal, porous coated metaphyseal sleeves in revision knee replacements.The authors present seven years of follow-up of the initial cohort.This is, as of yet, the longest follow-up report in literature.Products used: pfc & tc3, depuy index revision indications (figure 1): aseptic loosening infection stiffness (four of these patients were revised to a noiles, depuy and underwent manipulations under anesthesia with continued restricted flexion); one patient was in her mid-40¿s during index revision and had two further re-revisions for stiffness (these will be combined together due to insufficient information regarding the revisions), developed late infection four years after third revision and recently, in her mid-50¿s opted for a two-stage arthrodesis-it is reasonable to conclude that this late infection four years after the last revision was not related to the implant pain instability re-revision indications (figure 1): aseptic loosening (one patient revised for loosening had disengagement at the stem sleeve junction secondary to a technical error of tight fit of stem in femoral diaphysis) infection (two-stage procedure, transfemoral amputation, distal femoral replacement prosthesis used for reconstruction, antibiotic suppression therapy) persistent pain instability other notes: figure 3 reports migration of the tibial component (radiographic images) table 1 shows degree of bone loss in femur and tibia.The discussion section mentions multiple further procedures including amputation.The article does not discuss patellar resurfacing or cement manufacturer.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN KNEE FEMORAL SLEEVE
• Type of Device: KNEE FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9739250
• MDR Text Key: 189493343
• Report Number: 1818910-2020-05640
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL SLEEVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention