MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-706
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
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 implant did not insert into the tibial base during a ptg surgery.2 implants: size 7 thickness 8mm : no success.Use of a second cement.The surgeon had to change the implant of the femur because the cement has dried.Delay of surgery.
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.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: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
Event or Problem Description
Additional information received indicated that there was a 30-minute surgical delay.The reported event increased the patient's risk of infection.Affected side is the right side.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CR FB INSRT SZ 7 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11237401
• Report Number: 1818910-2021-01889
• Device Sequence Number: 19865012
• Product Code: JWH
• UDI-Device Identifier: 10603295045892
• UDI-Public: 10603295045892
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 01/14/2021

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: 1516-20-706
• Device Catalogue Number: 151620706
• Device Lot Number: J69P08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/01/2021; 03/23/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/11/2021; 03/24/2021
• 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 FB INSRT SZ 7 6MM.; ATTUNE CR FB INSRT SZ 7 6MM.; ATTUNE CR FB INSRT SZ 7 6MM.; ATTUNE CR FEM RT SZ 7 CEM.; ATTUNE CR FEM RT SZ 7 CEM.; SMARTSET GHV GENTAMICIN 40G.; UNKNOWN BONE CEMENT.; ATTUNE CR FB INSRT SZ 7 6MM; ATTUNE CR FB INSRT SZ 7 6MM; ATTUNE CR FEM RT SZ 7 CEM; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention