MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE REV LPS INSRT XSM 16MM; KNEE TIBIAL INSERT

Model Number 1517-60-216

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

Patient Problems Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 09/01/2022

Event Type  Injury  

Event Description

It was reported that the patient had implants removed and replaced due to suspected infection.Implants were placed on 2 dates per the records, (b)(6) 2019(first 5 items listed) and (b)(6) 2022.Patient experienced repeated effusions.Surgeon has sent multiple aspirations but no cultures were not positive.Cell counts and lab values were elevated, but not reaching a level to diagnose infection.During the procedure, 2 separate tissue samples were sent to pathology, and 3 and 4 wbc/hpf were found, again elevated but not definitive.Surgeon chose to removal all components and replace in a one stage fashion after a thorough debridement and irrigation.Antibiotic beads were placed in canals and surrounding soft tissues and vancomycin was added to gent cement.There was no surgical delay.Doi: (b)(6) 2019.Dor: (b)(6) 2022 affected side: left knee.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.

• Brand Name: ATTUNE REV LPS INSRT XSM 16MM
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15443149
• MDR Text Key: 300121329
• Report Number: 1818910-2022-18137
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295490982
• UDI-Public: 10603295490982
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1517-60-216
• Device Catalogue Number: 151760216
• Device Lot Number: JG6484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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: ATUN PRESSFIT STR STEM14X160MM; ATUN PRESSFIT STR STEM14X160MM; ATUN TIB SLV M/L 45MM FULL POR; ATUNE REV RP TIB BASE SZ 6 CEM; CONTROL CABLE W/CABLE SLEEVE; LPS DISTAL FEM COMP XSM LT; LPS FEM TO SLEEVE ADAPTER +0; LPS SEGMENTAL COMPONENT 25MM; LPS UNIV TIB HIN INS XSM 12MM; PFC*SIGMA/OV/DOME PAT 3PEG,41; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 75X20MM FLUTED; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 115 KG