MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV LPS INSRT XXSM 20MM; KNEE TIBIAL INSERT

Model Number 1517-60-120

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 03/19/2021

Event Type  Injury  

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 Description

It was reported that the implants removed were inserted on (b)(6) 2021.Der have been submitted on each of these dates with respective changes.Ultimately the graft that was placed in the patient became infected and all implants were removed.Antibiotic beads and a spacer was placed in the patient.No delay to surgery reported.Doi: (b)(6) 2021 (tibial tray, tibial stem, tibial sleeve, and control cable), doi: (b)(6) 2021 (distal femoral component, and femoral stem), doi: (b)(6) 2021 (femoral segmental components, and tibial insert), dor: (b)(6) 2021, right knee.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination 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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE REV LPS INSRT XXSM 20MM
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11602907
• MDR Text Key: 243516427
• Report Number: 1818910-2021-06817
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295491101
• UDI-Public: 10603295491101
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1517-60-120
• Device Catalogue Number: 151760120
• Device Lot Number: J63A42
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE REV LPS INSRT XXSM 20MM; ATUN TIB SLV M/L 45MM FULL POR; ATUNE PRESSFIT STR STEM20X60MM; ATUNE REV RP TIB BASE SZ 7 CEM; CONTROL CABLE W/CABLE SLEEVE; LPS CEMENTED STEM 15X125MM STR; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 35MM; LPS SEGMENTAL COMPONENT 65MM; UNKNOWN BONE CEMENT; ATTUNE REV LPS INSRT XXSM 20MM.; ATUN TIB SLV M/L 45MM FULL POR.; ATUNE PRESSFIT STR STEM20X60MM.; ATUNE REV RP TIB BASE SZ 7 CEM.; CONTROL CABLE W/CABLE SLEEVE.; LPS CEMENTED STEM 15X125MM STR.; LPS DISTAL FEM COMP XXSM RT.; LPS SEGMENTAL COMPONENT 25MM.; LPS SEGMENTAL COMPONENT 35MM.; LPS SEGMENTAL COMPONENT 65MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR