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

Catalog Number UNK KNEE TIBIAL TRAY SIGMA

Device Problems Loss of or Failure to Bond (1068); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 02/01/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: liu c, varady n, antonelli b, thornhill t, chen af.Similar 20-year survivorship for single and bilateral total knee arthroplasty.Knee.2022 mar;35:16-24.Doi: 10.1016/j.Knee.2022.02.001.Epub 2022 feb 14.Pmid: 35176554.Objective and methods: the purpose of this study was to compare implant survivorship between patients undergoing primary single, simultaneous bilateral, and staged bilateral total knee arthroplasty (tka) with 15-year minimum follow-up.Retrospective study included 826 patients (1089 knees), divided into single (454 knees), simultaneous bilateral (266 knees), or staged bilateral (369 knees) utilizing depuy sigma total knee implants.Reoperation was defined as all surgeries performed on the knee after the index procedure; revision tka was defined as complete implant exchange.Results: overall tka survival rates were very similar in all three groups (97.7% = simultaneous, 97.2% = staged, 96.7% = single).Simultaneous bilateral tkas exhibited similar range of motion, implant survival, and rates of reoperation to staged bilateral and single tka.The following numbers of complications requiring re-operations and revisions were reported: 5: infection-> surgical i&d washout.6: infection-> i&d washout with liner exchange.2: infection-> antibiotic spacer (definitive/complete explantation).3: infection-> single stage revision (complete revision tka).9: infection-> 2 stage revision (complete revision tka).2: implant bearing wear-tibial tray -> tibial tray exchange.2: implant bearing wear- polyethylene liner -> liner exchange.7: implant bearing wear- polyethylene liner w/ severe osteolysis -> complete revision tka.2: tibial tray implant loosening.1: femur implant loosening.4: severe osteolysis with femur & tibial tray loosening.9: arthrofibrosis-manipulation under anesthesia.3: arthrofibrosis-arthroscopic license of adhesions.1: arthrofibrosis-arthroscopic license of adhesions & liner exchange.4: periprosthetic femur fractures -> orif and total knee revision.3: extensor mechanism rupture.1: patella fracture -> orif.5: pain.1: pain w/ acl remnant and osteophyte - tissue excision liner exchange.1: pain w/ patella mal-tracking -> complete revision tka.1: pain w/ fat necrosis -> washout and tissue excision.1: pain -> meniscectom.1: pathologic lesion.1: avascular necrosis.

Manufacturer Narrative

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

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK KNEE TIBIAL TRAY SIGMA
• 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, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15027417
• MDR Text Key: 295967942
• Report Number: 1818910-2022-13080
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• 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 SIGMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• 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