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

Catalog Number UNK KNEE TIBIAL TRAY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Pain (1994); No Code Available (3191)

Event Date 09/18/2018

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, "total knee arthroplasty in severe valgus deformity using a modified techniques a 10-year follow-up study" written by adam tucker, mb, mrcs, mphil, seamus o'brien, phd, emer doran, bsc, dipn, nicola gallagher, phd, david e.Beverland, md, frcs published by the journal of arthroplasty made available online on 18 september 2018 was reviewed.The article's purpose was to report results from a 10 year follow up of a previously reported study.The previous study was reviewed and reported appropriately under (b)(4).This complaint will capture any newly reported adverse events within this article since the last study's article ((b)(4)).Cement manufacturer not identified.Patella resurfacing was not performed in any patient.Depuy product: uncemented lcs femoral, lcs insert, uncemented/cemented lcs tibial tray.Adverse events reported from previous study (refer to (b)(4)): tray subsidence (treated by revision), infection and/or hematoma (treated by washout only), spinout (treated by closed reduction and long-leg plaster).Adverse events to report from this article's 10 year follow up data: periprosthetic fracture (femoral, treated by open reduction internal fixation or im nail) pus in knee (infection culture was negative, treated by washout only, continues to have pain at 10 year follow up)."knee stiffness" (treated by manipulation under anesthesia).

Manufacturer Narrative

Product complaint # : (b)(4).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 code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: UNKNOWN KNEE TIBIAL TRAY
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10313938
• MDR Text Key: 200782443
• Report Number: 1818910-2020-16659
• Device Sequence Number: 1
• Product Code: JWH
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention