MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE TIBIAL INSERT LCS

Catalog Number UNK KNEE TIBIAL INSERT LCS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Embolism (1829); Hematoma (1884); Unspecified Infection (1930); Thrombosis (2100); Impaired Healing (2378); No Code Available (3191)

Event Date 09/24/2019

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.

Event Description

The literature article entitled, "a prospective randomized study comparing postoperative pain, biological fixation, and clinical outcomes between two uncemented rotating platform tibial tray designs" written by paul hegarty, mb bch, mrcs , andrew walls, mb bch, mrcs, seamus o¿brien, phd, barbara gamble, bsc, laurence cusick, mphil, frcs, and david e.Beverland, md, frcs published by the journal of arthroplasty made available online on 24 september 2019 was reviewed.The article's purpose to study if the biological interface of ha coating and tray design would provide a reduction in time to implant osseointegration, allowing for normal physiological stress transfer, thus improving early postoperative pain and rehabilitation.Data was compiled from 91 knees at the 10 year endpoint.A comparison between lcs complete duofix and lcs complete porocoat coatings.Cement manufacturer is not identified and patella resurfacing was not performed.Depuy product: lcs complete.Adverse events: infection (treated by revision/washout).Superficial wound infection (treated by antibiotics).Spin out of liner (spontaneously reduced and needed no further intervention).Femoral periprosthetic fracture (treated by orif).Partial patellar tendon avulsion (no treatment provided).Prolonged wound ooze (no further information).Hematoma (no information regarding treatment).Femoral dvt (no information regarding treatment).Pulmonary embolism (no information regarding treatment).

Manufacturer Narrative

Product complaint # (b)(4).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.Corrected: h6 (device).

• Brand Name: UNK KNEE TIBIAL INSERT LCS
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10665415
• MDR Text Key: 211020946
• Report Number: 1818910-2020-22015
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL INSERT LCS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention