MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-506

Device Problem Naturally Worn (2988)

Patient Problems Edema (1820); Pain (1994); Synovitis (2094); Not Applicable (3189); No Code Available (3191)

Event Date 01/04/2017

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 concomitant medical products: 2018.Records indicated patient's left attune knee was revised to address pain, catastrophic varus deformity from implant collapse, and aseptic loosening of the tibial base plate, at the cement to implant interface.Surgeon indicated tibial base plate component was grossly loose.Stated there was tibia bone loss where the tibia was impacted by the loose component.Tibial cement mantle was well-fixed, as was the revised femur component.Indicated that there was mild poly-wear type synovitus.Reported that the patient's native patella had not been resurfaced when the primary was performed.There was no evidence of acute infection.Competitor bone cement used for primary.Doi: (b)(6) 2014; dor: (b)(6) 2017; (left knee).

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no product associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.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

H6(b)(4).These information has been reported in (b)(4) with an mfr number 1818910-2019-112846.Mfr number 1818910-2019-112846 has been retracted due to a duplicate of this mfr number 1818910-2018-61693.

Event Description

Medical records received ad 17 june 2019.The patient underwent a left knee revision due to tibial tray migration, malpositioning, and loosening at the cement to implant interface.The surgeon noted effusion, mild poly wear-type synovitis, and tibial bone loss.The patella was not resurfaced during the primary operation.Competitor cement was used during the primary operation.Doi: (b)(6) 2014; dor: (b)(6) 2017; left knee.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary:no product associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: h6 (patient).H6 patient code: no code available (3191) was used to capture surgical intervention.

• Brand Name: ATTUNE PS FB INSRT SZ 5 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7583589
• MDR Text Key: 110522700
• Report Number: 1818910-2018-61693
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295049937
• UDI-Public: 10603295049937
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 1516-40-506
• Device Catalogue Number: 151640506
• Device Lot Number: 367018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR