MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS RP INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-50-608

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Joint Disorder (2373); Not Applicable (3189); No Code Available (3191)

Event Date 05/02/2018

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

Patient was revised to address pain and instability.Doi: (b)(6) 2016.Dor: (b)(6) 2018.Left knee.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.

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.

Event Description

Medical records received ad 17 june 2019.The patient underwent a left knee revision due to pain and instability.Pre-operative exam was notable for flexion gap laxity.The surgeon noted the femoral component was found to be secure, however, it was noted to be approximately 10 degrees internally rotated relative to the trans-epicondylar axis, which aggravated the lateral side flexion gap.The femoral component and patella component were both well-fixed and not revised.Competitor cement was used during the primary operation.Doi: (b)(6) 2016; dor: (b)(6) 2018; left knee.

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.

• Brand Name: ATTUNE PS RP INSRT SZ 6 8MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7556326
• MDR Text Key: 109625478
• Report Number: 1818910-2018-60949
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295052593
• UDI-Public: 10603295052593
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 1516-50-608
• Device Catalogue Number: 151650608
• Device Lot Number: 8290408
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 38MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 103