MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE REV LPS INSRT XXSM 12MM; KNEE TIBIAL INSERT

Catalog Number 151760112

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

The patient was revised due to loosening of the stem and attune femoral sleeve at the bone to implant interface.Patient came in to er with dislocated depuy lps distal femoral replacement.While opening to revise, it was also apparent that the knee was infected.All implants were removed except the tibia baseplate, tibial sleeve and stem.Antibiotic spacer implanted.Doi: (b)(6) 2023.Dor: (b)(6) 2023.Affected side: unknown.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary = no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A complaint database search did find additional related reports against the provided product code and lot number combination(s) for infection(similar allegations noted).Since allegation is not related to manufacturing, mre will not be performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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 XXSM 12MM
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17948383
• MDR Text Key: 325799608
• Report Number: 1818910-2023-21093
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295491064
• UDI-Public: 10603295491064
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 151760112
• Device Lot Number: JN0949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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: ATT REV SLV LPS FEM ADP +0; ATUN FEM SLV M/L 40MM FULL POR; ATUN PRESSFIT STR STEM14X110MM; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 25MM
• Patient Outcome(s): Required Intervention
• Patient Sex: Male