MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE RP TIB BASE SZ 3 POR; ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150611003
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
The patient was revised to address pain, discomfort and loosening of the tibial component at the bone to implant interface.The x-rays showed slight radiolucency on the tibial component.The surgeon opened up the knee and saw a bit of micro motion so the poly and tibia were replaced.Doi: (b)(6) 2018; dor: (b)(6) 2019; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device 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.

• Brand Name: ATTUNE RP TIB BASE SZ 3 POR
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8429548
• Report Number: 1818910-2019-87623
• Device Sequence Number: 13788417
• Product Code: NJL
• UDI-Device Identifier: 10603295416258
• UDI-Public: 10603295416258
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 150611003
• Device Lot Number: 8421517
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR