MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 29MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number	1518-20-029
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Not Applicable (3189); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Is an attorney.
Event or Problem Description
Received medical records on 06/11/2018.Medical records reviewed for mdr reportability.Left attune total knee revised to address pain, and aseptic loosening of the tibial base plate identified by radiographs.Revising surgeon noted that the femur was well-fixed, but tibial base plate was notably loose, lifting out of the cement mantle.Also noted medial subsidence of the tibia, and medial osteolysis and osteonecrosis beneath the tibial cement mantle.Femur and patella were retained; tibial base plate and insert were revised.Depuy cement was used for primary.Doi: (b)(6) 2016; dor: (b)(6) 2018; (left knee).
Additional Manufacturer Narrative
Correction to block (b)(4) as it was discovered that the date reported on the initial report was incorrect.
Additional Manufacturer Narrative
(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.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.
Additional 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 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.  patient code 3191 is intended for surgical intervention.
Additional 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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.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.Updated 14 may 2020 re-open the complaint was re-opened upon receiving the patient¿s medical record information.The information received did not change the original investigation report device history lot : null device history batch : null device history review : null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE MEDIAL DOME PAT 29MM
• Common Device Name: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7731299
• Report Number: 1818910-2018-65422
• Device Sequence Number: 11140726
• Product Code: JWH
• UDI-Device Identifier: 10603295056669
• UDI-Public: 10603295056669
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 1518-20-029
• Device Catalogue Number: 151820029
• Device Lot Number: 8373368
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/27/2018; 08/02/2018; 06/17/2019; 05/14/2020
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 07/31/2018; 08/08/2018; 07/01/2019; 05/15/2020
• 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