MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 4 4MM; KNEE FEMORAL ACCESSORY

Model Number	1547-04-001
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient was revised to treat infection and loosening of the femoral component at the cement to implant interface.Depuy cement was utilized.Patient received a temporary spacer.Doi: (b)(6) 2019; dor: (b)(6) 2021; unknown knee.
Additional Manufacturer Narrative
Product complaint # : pc-(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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE DIST FEM AUG SZ 4 4MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11838976
• Report Number: 1818910-2021-10511
• Device Sequence Number: 19568125
• Product Code: JWH
• UDI-Device Identifier: 10603295382713
• UDI-Public: 10603295382713
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 1547-04-001
• Device Catalogue Number: 154704001
• Device Lot Number: J0453A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/08/2021
• 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 CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL RT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 8MM; ATTUNE DIST FEM AUG SZ 4 4MM; ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE POS FEM AUG SZ 4 4MM; ATTUNE POS FEM AUG SZ 4 8MM; ATUNE REV RP TIB BASE SZ 5 CEM; SMARTSET GMV GENTAMICIN 40G; SMARTSET GMV GENTAMICIN 40G; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL RT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 8MM; ATTUNE DIST FEM AUG SZ 4 4MM; ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE POS FEM AUG SZ 4 4MM; ATTUNE POS FEM AUG SZ 4 8MM; ATUNE REV RP TIB BASE SZ 5 CEM; SMARTSET GMV GENTAMICIN 40G; SMARTSET GMV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention