MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ5 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-507
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The primary surgery was performed on (b)(6) 2015 for the patient¿s right knee joint via tka.The revision surgery which was scheduled on (b)(6) 2020 was performed on schedule due to poor stability.The surgeon plans to replace the tibial insert as the first choice.The surgery was completed without any surgical delay.The surgeon replaced the tibial insert.He commented that the tibial insert might have not been locked.
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.Device history lot : product code 151620507, work order 7803788 was manufactured on 09-dec-2013.31 parts were manufactured per specification and all raw materials met specification.There was no scrap associated with this lot.No reprocessing associated with this lot there were no ncs or deviations associated with this lot.Expiry date: nov-2018.Ifu reference: 090200828.

• Brand Name: ATTUNE CR FB INSRT SZ5 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10669752
• Report Number: 1818910-2020-22102
• Device Sequence Number: 2508746
• Product Code: JWH
• UDI-Device Identifier: 10603295045663
• UDI-Public: 10603295045663
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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 Model Number: 1516-20-507
• Device Catalogue Number: 151620507
• Device Lot Number: 7803788
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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: UNK ATTUNE FEMORAL; UNK ATTUNE KNEE TIBIAL TRAY; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR