MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 6 14MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-614

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Pain (1994); Joint Disorder (2373); No Code Available (3191)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised due to loosening of the tibial component at cement to implant interface.Cement manufacturer is unknown.This patient had bilateral attuned.The right tibia was revised previously.Mdr done for that revision as well.Doi: (b)(6) 2016, dor: (b)(6) 2020, left knee.

Manufacturer Narrative

Product complaint (b)(4).Corrected: b4 (alert date).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).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: d10 corrected: g1.

• Brand Name: ATTUNE PS FB INSRT SZ 6 14MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10516378
• MDR Text Key: 206386558
• Report Number: 1818910-2020-19720
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050124
• UDI-Public: 10603295050124
• 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
• Report Date: 01/31/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 1516-40-614
• Device Catalogue Number: 151640614
• Device Lot Number: 556080
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 08/25/2020; 04/09/2021
• Supplement Dates FDA Received: 09/10/2020; 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 6 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 133