MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 41MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-041

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the surgeon did revision surgery on (b)(6) 2019 at (b)(6).The knee is now infected so the surgeon removed all components and put in an antibiotic knee spacer.Doi: (b)(6) 2019, dor: (b)(6) 2021.(right knee).

• Brand Name: ATTUNE MEDIAL DOME PAT 41MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12496644
• MDR Text Key: 272197665
• Report Number: 1818910-2021-20510
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056706
• UDI-Public: 10603295056706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1518-20-041
• Device Catalogue Number: 151820041
• Device Lot Number: 9269056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 24MM; ATTUNE DIST FEM AUG SZ 6 8MM; ATTUNE DIST FEM AUG SZ 6 8MM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE POS FEM AUG SZ 6 8MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM18X60MM; ATUNE PRESSFIT STR STEM20X60MM; ATUNE REV RP TIB BASE SZ 6 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR