MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 8 4MM; KNEE FEMORAL ACCESSORY

Model Number	1547-08-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/22/2021
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
Clinical notification received for revision of left total knee to address infection.Date of implantation: (b)(6) 2019, date of revision: (b)(6) 2021, (left knee).Treatment: revision of all products (femur construct, tibial construct, insert, and patella components).
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.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.
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.
Event or Problem Description
Medical records received indicated that the primary operative notes and the first revision procedure notes were not provided within this set of medical records.It is unknown, at this time, what the manufacturer of the primary implants or first revision surgery were.Unknown if depuy ¿ dates of primary and first revision surgeries also not provided.Revision operative notes (b)(6) 2019 indicate the patient received a left total knee revision due to infection.It is unknown if depuy products were implanted at this surgery.Re-implantation operative notes (b)(6) 2019 indicate the patient received a left total knee re-implantation due to infection markers were satisfactory for re-implantation.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2021 indicate the patient received a left total knee revision due to infection.The surgery was completed without indication of complication by the surgeon.(b)(4).Revision operative notes (b)(6) 2021 indicate the patient received a left total knee revision due to pain, swelling and hematogenous spread of infection.The surgery was completed without indication of complication by the surgeon.(b)(4).

• Brand Name: ATTUNE DIST FEM AUG SZ 8 4MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12705485
• Report Number: 1818910-2021-23726
• Device Sequence Number: 4550561
• Product Code: JWH
• UDI-Device Identifier: 10603295382850
• UDI-Public: 10603295382850
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• 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: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1547-08-001
• Device Catalogue Number: 154708001
• Device Lot Number: J31N91
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 11/23/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/18/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 14MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 8MM; ATUN FEM SLV M/L 40MM FULL POR; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM20X60MM; ATUNE REV RP TIB BASE SZ 7 CEM; DEPUY CMW 2 20G; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; UNK ATTUNE KNEE PATELLA; ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 14MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 8MM; ATUN FEM SLV M/L 40MM FULL POR; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM20X60MM; ATUNE REV RP TIB BASE SZ 7 CEM; DEPUY CMW 2 20G; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; UNK ATTUNE KNEE PATELLA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic