MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 5 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-10-005

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 08/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of the medical records for mdr reportability, the patient underwent a primary left knee on (b)(6) 2015 and was revised on (b)(6) 2016 due to pain and tibial loosening (unknown interface).At this time no primary operative note or part/ lot information was been provided, so its unknown if depuy implants were implanted.It should be noted all implants were revised and competitor products were placed at revision.Doi: (b)(6) 2015.Dor: (b)(6) 2016, (left knee).

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE RP TIB BASE SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9545061
• MDR Text Key: 173534819
• Report Number: 1818910-2020-00268
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042594
• UDI-Public: 10603295042594
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-10-005
• Device Catalogue Number: 150610005
• Device Lot Number: 7916282
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FEM LT SZ 6 CEM; ATTUNE PS RP INSRT SZ 6 7MM; COMPETITOR CEMENT; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FEM LT SZ 6 CEM; ATTUNE PS RP INSRT SZ 6 7MM; COMPETITOR CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 101