MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS DISTAL FEM COMP XSM LT; LPS AND S-ROM : KNEE FEMORAL

Model Number 1987-13-105

Device Problems Loss of or Failure to Bond (1068); No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2022

Event Type  Injury  

Event Description

Revision of depuy tkr components for implant loosening.Left knee.Lot numbers not sourced.Implants discarded.Doi: (b)(6) 2009, dor (12th): (b)(6) 2021.Dor (13th): (b)(6) 2022.

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.

Manufacturer Narrative

Product complaint (b)(4).Information was received indicating that "the femoral components were removed solely for access to the tibia." due to this, depuy synthes joint reconstruction considers the device on this report to be not reportable as there is no allegation of deficiency or patient harm, additional follow up is being conducted.Further updates will only be provided if additional information is received that changes the regulatory determination.

• Brand Name: LPS DISTAL FEM COMP XSM LT
• Type of Device: LPS AND S-ROM : KNEE FEMORAL
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15649687
• MDR Text Key: 302169486
• Report Number: 1818910-2022-21056
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295078685
• UDI-Public: 10603295078685
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1987-13-105
• Device Catalogue Number: 198713105
• Device Lot Number: J64R18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2019
• 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 REV LPS INSRT XSM 12MM; ATUN PRESSFIT STR STEM18X110MM; ATUN TIB SLV M/L 53MM FULL POR; ATUNE REV RP TIB BASE SZ 7 CEM; LPS DISTAL FEM COMP XSM LT; LPS FEM TO SLEEVE ADAPTER +0
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male