MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-003

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Medical devices: attune medial dome pat 32mm 151820032 lot: 3476948, attune ps fem lt sz 5 nar cem 150410125 lot: 402078, attune ps fb insrt sz 5 5mm 151640505 lot: 411156.

Event Description

Received medical records on (b)(6) 2018.Medical records reviewed for mdr reportability.Left attune total knee revised to address pain and aseptic loosening of the tibial base plate.Revising surgeon identified an amyloid type tissue in the knee rather than synovitis.He also indicated that the tibial base plate "fell out" and was "probably as loose as he's ever seen" one.The cement mantle required removal following the explantation of the tibial component.Femur, tibial insert and patellar components were also revised, but no product failures were identified with regard to these products.Depuy cement was used at primary.A competitor knee system was used to revise the knee.Doi: (b)(6) 2013; dor: (b)(6) 2017; (left knee).

Manufacturer Narrative

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 medwatch, a follow-up medwatch will be filed as appropriate.

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.H6 patient code: no code available (3191) was used to capture surgical intervention.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.Device history lot : null.Device history batch : null.Device history review : null.

• Brand Name: ATTUNE FB TIB BASE SZ 3 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7756267
• MDR Text Key: 116209797
• Report Number: 1818910-2018-65860
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042372
• UDI-Public: 10603295042372
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1506-00-003
• Device Catalogue Number: 150600003
• Device Lot Number: 3584504
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR