MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-712

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Synovitis (2094); No Code Available (3191)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

(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 suspected loosening of the tibial tray at cement to implant interface.Depuy cement was used.Attune tibial tray was found to be grossly loose.Some pitting was observed on the poly insert.Patient was revised to a stemmed attune fixed bearing revision tray with 2 10mm wedges, and a new poly insert.Doi: (b)(6) 2016; dor: (b)(6) 2019; right 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.

Event Description

Medical records alleges synovitis.

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:   udi:(b)(4).Added: b5, b7, d4 (expiration), g3, h6 (patient) and d11.No code available was added to capture medical device removal.

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.H10 additional narrative: corrected: g1.

• Brand Name: ATTUNE PS FB INSRT SZ 7 12MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8753358
• MDR Text Key: 149797705
• Report Number: 1818910-2019-97439
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050254
• UDI-Public: 10603295050254
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• 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
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 1516-40-712
• Device Catalogue Number: 151640712
• Device Lot Number: 469013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 41MM.; ATTUNE PS FEM RT SZ 7 CEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR