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

Catalog Number 150610008

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Edema (1820); Pain (1994); Joint Disorder (2373); No Known Impact Or Consequence To Patient (2692); Not Applicable (3189); No Code Available (3191)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Der states that the patient came in for a revision total knee.Once inside the knee it was determined that the tibial base plate had debonded from the implant.Surgeon removed rotating platform tray and replaced with a stemmable attune fixed bearing implant.Surgeon also put a patella in the patient as it was not resurfaced on the original surgery.There was also loosening of the tibia at the cement to implant interface, unknown cement manufacturer was used.Doi: (b)(6) 2017, dor: (b)(6) 2018, right knee.

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).Investigation summary
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> 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.

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.

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.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.

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.

Event Description

Medical records received on 17 jun 2019 were reviewed to identify patient harms/product issues on 05 november 2019.On (b)(6) 2018, the patient underwent a right knee revision due to loosening of the tibial component, instability, swelling, and pain.The surgeon reported overall gross instability.He indicated evidence of chronic subluxation with some poly wear.The surgeon indicated the tibial component had de-bonded from the cement mantle.He noted the femoral component was in good position, well cemented to the bone, and no evidence of de-bonding or separation.The patella was revised.The surgeon reported no intraoperative complications.The patient was implanted with attune knee system and competitor cement doi: (b)(6) 2017 dor: (b)(6) 2018 (rt knee).

• 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 ; EI
• MDR Report Key: 7574414
• MDR Text Key: 110267889
• Report Number: 1818910-2018-61507
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 150610008
• Device Lot Number: 8410895
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 07/06/2018; 11/05/2019; 11/05/2019; 12/13/2019
• Supplement Dates FDA Received: 07/17/2018; 12/02/2019; 12/03/2019; 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FEM RT SZ 9 CEM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 115