MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR CR LT SZ 4; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-01-104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/24/2020
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) 2020 via tka for the patient¿s left knee joint.On (b)(6) 2020, the revision surgery was performed due to spin-out (this event was reported as (b)(4)).It was reported that the second spin-out occurred, and the removal surgery was performed on (b)(6) 2020 by removing the tibial insert (p/n: 151630407), the femoral component (p/n: 150401104) and the tibial tray (p/n: 150611004).The surgery was completed without surgical delay.No further information is available.
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 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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no additional related incident(s) against the provided product/lot combination(s) 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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 patient code: no code available (3191) used to capture joint instability.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.H10 additional narrative: added: b5 and h6.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
Additional information received stated that the surgeon commented that the spin-out which occurred 2 weeks after the primary surgery was caused by bad balance of extension and flexing, it was a technical error.
Event or Problem Description
Additional information received that the surgeon commented that the spin-out which occurred 2 weeks after the primary surgery was caused by bad balance of extension and flexing, which was a technical error.
Additional Manufacturer Narrative
Product complaint # : (b)(4).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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE FEM POR CR LT SZ 4
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10030546
• Report Number: 1818910-2020-11772
• Device Sequence Number: 3696468
• Product Code: NJL
• UDI-Device Identifier: 10603295041337
• UDI-Public: 10603295041337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1504-01-104
• Device Catalogue Number: 150401104
• Device Lot Number: 8757872
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 05/11/2020; 04/23/2020; 06/03/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 05/12/2020; 05/19/2020; 06/04/2020
• 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 RP INSRT SZ4 7MM; ATTUNE FEM POR CR LT SZ 4; ATTUNE RP TIB BASE SZ 4 POR
• Outcome Attributed to Adverse Event: Required Intervention