MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 4 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-406
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient received left primary attune tka to treat knee pain secondary to osteoarthritis.The patella was resurfaced, and depuy cement x 2 was utilized.The procedure was completed without complications.Patient receive a left knee revision due instability secondary to loosening of the tibial insert.Upon entering the joint, the insert was noted to be dislocated and externally rotated on the medial side and no longer under the femoral component causing a large laxity on the femoral side.The femoral component, tibial tray, and patella were well-fixed and retained.The manufacturer of the revised tibial insert was not provided.The procedure was completed without complications.Doi: (b)(6) 2016; dor: (b)(6) 2018; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 CR RP INSRT SZ 4 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10134280
• Report Number: 1818910-2020-13469
• Device Sequence Number: 14419608
• Product Code: NJL
• UDI-Device Identifier: 10603295047636
• UDI-Public: 10603295047636
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 1516-30-406
• Device Catalogue Number: 151630406
• Device Lot Number: 8271870
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FEM LT SZ 4 CEM.; ATTUNE MEDIAL DOME PAT 35MM.; ATTUNE RP TIB BASE SZ 4 CEM.; SMARTSET GMV 40G US EO.; SMARTSET GMV GENTAMICIN BONE CEMENT.; ATTUNE CR FEM LT SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV GENTAMICIN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR