MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL TRAY

Catalog Number UNK ATTUNE KNEE TIBIAL TRAY

Device Problems Loss of or Failure to Bond (1068); Unintended Movement (3026); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 05/01/2020

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.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 patient was revised to address fall and loosening of the tibial component at the cement to implant interface.Patient had a primary knee done on (b)(6) 2014.It progressed more and more into varus.Implant product and lot numbers are unavailable however they know it was a sz4 ps attune femur, 38mm attune dome patella, sz3 attune cemented tibial fb tray, sz4x8 fb attune ps tibial insert.The insert and tibial tray was revised to a rp revision tray / sleeve / stem and insert.Patella and femoral component were not removed.Unknown cement was used.No surgical delay.Doi: (b)(6) 2014.Dor: (b)(6) 2020; unknown side of the knee.

Manufacturer Narrative

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.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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK ATTUNE KNEE TIBIAL TRAY
• Type of Device: UNK ATTUNE KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10061494
• MDR Text Key: 191125637
• Report Number: 1818910-2020-12151
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN ATTUNE FEMORAL; UNKNOWN ATTUNE PATELLA; UNKNOWN ATTUNE TIBIAL INSERT; UNKNOWN BONE CEMENT; UNKNOWN ATTUNE FEMORAL; UNKNOWN ATTUNE PATELLA; UNKNOWN ATTUNE TIBIAL INSERT; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention