MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE RP TIB BASE SZ 8 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-10-008

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Scarring (2061); Swelling (2091); No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/19/2017

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.

Event Description

Patient was revised to address loosening of the tibial component at cement to implant interface.Competitor cement was used.No cement fixation was present between the implant and cement.Doi: unknown; dor: (b)(6) 2017; left knee'.

Manufacturer Narrative

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

Event Description

Medical records received ad 17 jun 2019 were reviewed on 10 jul 2019 for mdr reportability.Primary operative notes (b)(6) 2017 indicate the patient received a left total knee replacement due to pain, osteoarthritis and varus deformity.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2017 indicate the patient received a left total knee revision due to persistent effusions, swelling, pain and failed left total knee arthroplasty, secondary to tibial component loosening.Upon entering the knee, the surgeon noted a large effusion and dense scarring.It is also indicated that the tibial component was loose at the both the cement-to-implant and cement-to-bone interfaces.The surgery was completed without indication of complication by the surgeon.Competitor cement was utilized at the primary procedure.Doi: (b)(6) 2017.Dor: (b)(6) 2017.(left knee).

Manufacturer Narrative

Product complaint # (b)(4).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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).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.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) used to capture the surgical intervention.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.H10 additional narrative: corrected:h6.Added:d10,h3,h1,h6(device).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 - a device history record (dhr) review was conducted on (b)(4).Product code 150610008, work order 8365907 was manufactured on (b)(6) 2016.20 parts were manufactured per specification and all raw materials met specification.There were no ncs or deviations associated with this lot.Review of the dhrs did not reveal any related manufacturing deviations or anomalies on the provided product and lot combination.Device history batch - null.Device history review - null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE RP TIB BASE SZ 8 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7185561
• MDR Text Key: 97073025
• Report Number: 1818910-2018-51056
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042624
• UDI-Public: 10603295042624
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1506-10-008
• Device Catalogue Number: 150610008
• Device Lot Number: 8365907
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 41MM.; ATTUNE PS FEM LT SZ 8 CEM.; PALACOS R+G BONE CEMENT WITH GENTAMICIN.; PALACOS R+G BONE CEMENT WITH GENTAMICIN.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR