MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CEMENTED STEM 14X80MM; KNEE STEMS

Model Number	1512-14-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for low grade infect event is serious and is considered severe event is probably related to device and is probably related to procedure.Date of implantation: (b)(6) 2018, date of event (onset): (b)(6) 2021, (right knee).Treatment: revision of tibial base plate, tibial stem, tibial insert, and femur components.
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.
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 : bfarm dhr review was performed for product/lot combination 151214080/hm9845.1) quantity manufactured: (b)(4).2) date of manufacture: 01/18/2018.3) any anomalies or deviations identified in dhr: na.4) expiry date: 2027-11-30.5) ifu reference:(b)(4).

• Brand Name: ATTUNE CEMENTED STEM 14X80MM
• Common Device Name: KNEE STEMS
• 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: 13000463
• Report Number: 1818910-2021-27838
• Device Sequence Number: 12087751
• Product Code: JWH
• UDI-Device Identifier: 10603295475170
• UDI-Public: 10603295475170
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 1512-14-080
• Device Catalogue Number: 151214080
• Device Lot Number: HM9845
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 12/15/2021; 02/01/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/11/2022; 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• 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 CEMENTED STEM 14X80MM; ATTUNE PS FB INSRT SZ 6 5MM; ATTUNE PS FEM RT SZ 6 CEM; ATUNE CRS FB TIB BASE SZ 6 CEM; SMARTSET GHV GENTAMICIN 20G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 151 KG