MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE TIBIAL TRAY UNI

Catalog Number UNK KNEE TIBIAL TRAY UNI

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pulmonary Embolism (1498); Cellulitis (1768); Bone Fracture(s) (1870); Muscular Rigidity (1968); Pain (1994); Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440); Joint Laxity (4526); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

Event Description

The literature article titled, " total versus partial knee replacement in patients with medical compartment knee osteoarthritis: the topkat rct" written by david j.Beard, loretta j.Davies, jonathan a.Cook, graeme maclennan, andrew price, seamus kent, jemma hudson, andrew carr, jose leal, helen campbell, ray fitzpatrick, nigel arden, david murray and marion k.Campbell on behalf of the topkat study group published by nihr journals library volume april 2020 was reviewed.The article is a comprehensive report of a large study involving final follow ups for 258 patients (recruited from january 2010 to september 2013) at 27 hospitals and 68 experienced surgeons.To start there were 264 pkrs and 264 tkas.The report measured yearly scores and measure for pain, function, success rate of operation and costs for each patient for 5 years.It is noted that depuy products are listed amongst products utilized for both tka (total knee arthroplasty) and pkr (partial knee replacement).The article does not specify which specific products (depuy or non-depuy) are related to specific adverse events and only measures count by either tka or pkr category.Therefore, exact quantities of products involved cannot be determined.The final conclusion of the study was that both surgical procedures are effective, offer similar clinical outcomes and have similar reoperation and complication rates.This complaint captures the adverse events that are possibly related to depuy implants.Various cement manufacturer were utilized and patellar resurfacing was performed in 22 total patients (specific manufacturer is not identified).Some participants were lost in follow up and those deceased are not identified to be related to implant or procedure.Pkr depuy products in performed procedures: unknown depuy knee construct (femoral, insert, and tray) - qty 4 patients, sigma uni (femoral, insert, and tray) - qty 1 patient, cmw i cement (qty 11 patients).Pkr adverse events (table 10, page 39; table 13, page 46; table 28, page 85): post operative complications of cellulitis, respiratory problems, renal and urological problems, treated dvt/pe, cardiac problem, anesthetic problems, stiffness, instability, wound infection.Readmissions requiring medical treatment: unexplained pain, bearing dislocation, cellulitis, superficial infection.Revisions for unexplained pain, bearing dislocation, tibial device loosening (interface unknown), ligamentous instability, infection, periprosthetic fracture (no further information provided).Other interventions with out further information include aspiration, arthroscopy, debridement/exploration/washout, open reduction and internal fixation of avulsion fracture of tibial tuberosity, marcaine injection, mua (manipulation under anesthetic), surgery for skin complication.Tka depuy products in performed procedures: lcs construct (femoral, insert, tray, and patella) - qty 71 total patients, pfc sigma (femoral, insert, tray, and patella) - qty 57 total patients, cmw i cement (qty 18 patients).Tka adverse events (table 10, page 39; table 13, page 46, table 28, page 85): intraoperative complications: unspecified medical reasons, requirement of blood transfusion.Post operative complications: requirement of blood transfusion, respiratory problems, renal and urological problems, treated dvt/pe, cardiac problem, stiffness, instability, periprosthetic fracture.Readmissions requiring medical treatment: unexplained pain, wound breakdown, broncho pneumonia, cardiac problems, treated dvt/pe.Revisions for unexplained pain, infection with mechanical failure (no further information), unknown reasons, knee stiffness, ligamentous instability and malalignment (no further information provided), tibial device loosening (interface unknown) other interventions without further information include mua, aspiration, arthroscopy, debridement/exploration/washout, marcaine injection, biopsy, partial medial meniscectomy.Complications without categorized group (table 31 page 88): acute respiratory failure, atrial fibrillation, acute kidney injury, chest infection, dural tear, hyponatremia, hypoxemia, pe, pneumonia, pyrexia, and urinary retention.

• Brand Name: UNK KNEE TIBIAL TRAY UNI
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11250774
• MDR Text Key: 233290776
• Report Number: 1818910-2021-02054
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL TRAY UNI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2021
• 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