MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE RP TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150610006

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Joint Disorder (2373); Not Applicable (3189); No Code Available (3191)

Event Date 08/30/2017

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

Reviewed medical records received on (b)(6) 2018.Right knee revised to address pain, and instability.Revising surgeon noted that tibia base plate appeared visually to not be loose, until a trial insert was placed in the tray.At that point, it was obvious that the tibia base plate was loose, lifting clean off the cement mantle effortlessly.The femur component was fairly well-fixed, requiring osteotomes to extract.The tibia cement mantle was well-fixed to the tibia bone, reported to be difficult to remove.The patella was retained.No product or lot code information provided for attune system.Cement manufacturer for primary knee is unknown.A competitor knee system was re-implanted.Doi: (b)(6) 2016; dor: (b)(6) 2017; (right knee).

Manufacturer Narrative

Product complaint # (b)(4).Concomitant med products: attune ps fem rt sz 6 cem; attune ps rp insrt sz6 5mm; attune patella; smartset hv bone cement 40g x 2.

Manufacturer Narrative

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).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.H6 patient code: no code available (3191) used to capture the surgical intervention.

• Brand Name: ATTUNE RP TIB BASE SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7587539
• MDR Text Key: 110641170
• Report Number: 1818910-2018-61793
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150610006
• Device Lot Number: 8098235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: SEE H10 ENTRY
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR