MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL SLEEVE; UNK KNEE TIBIAL SLEEVE

Catalog Number UNK KNEE TIBIAL SLEEVE

Device Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ossification (1428); Adhesion(s) (1695); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 01/01/2019

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, "long-term results of total knee arthroplasty with contemporary distal femoral replacement" written by cody c.Wyles, md, meagan e.Tibbo, md, brandon j.Yuan, md, robert t.Trousdale, md, daniel j.Berry, md, and matthew p.Abdel, md published by the journal of bone and joint surgery, incorporated 2019 was reviewed.The article's purpose was to discuss long-term result of tka with distal femoral replacement and included primary and revision surgeries.Data was compiled from 144 patients and it is noted that 9 depuy lps systems were utilized amongst non-depuy tka systems.The article does not identify cement manufacturer but notes that all femoral stems were cemented.Original implants of revision surgeries were not identified.Patellar resurfacing was not discussed.Patient age range 23-96 years old.Some patients were lost to follow up and some died of unrelated causes but all 144 were included in the analysis of the article.Only the follow up range of 2 to 13 years was taken into account for 111 patients.The article does not specify which adverse events are associated with specific products.The article does not provide adequate information to determine accurate quantities.The article provides radiographic imaging in figures 4a-c along with patient identifiers but caption description does not identify the implants as depuy or non-depuy, and their adverse events have been grouped in the combined results of adverse events.Depuy implants: lps distal femoral system (distal femoral stem, femoral component, hinge pin, and hinged insert; tibial tray, tibial sleeve, tibial stem).Adverse events: periprosthetic joint infection (treated with revision or above-the knee amputation).Dissociation of the component from the stem (treated with revision).Rotating-hinge bushing failure - no further details provided (treated with revision).Stem fracture (treated with revision).Periprosthetic fracture - no further details provided (treated with revision or open reduction and internal fixation).Arthrofibrosis with heterotopic ossification (treated by revision or capsular release).Modular junction metallosis - no further details provided (treated by revision).Extensor mechanism failure (treated by revision or reconstruction).Anterior knee pain (treated by revision).Infections and wound complications - no further details provided (treated by irrigation and debridement).Aseptic loosening - no further details provided (treated with revision).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.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.

• Brand Name: UNKNOWN KNEE TIBIAL SLEEVE
• Type of Device: UNK KNEE TIBIAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10036393
• MDR Text Key: 190486456
• Report Number: 1818910-2020-11853
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL SLEEVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention