MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE FEM CEM R SM+; LCS COMPLETE : KNEE FEMORAL

Model Number	1294-01-020
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	10/03/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The primary surgery was performed about 15 years ago via tka with lcs implants.It was reported that the patient had a pain and loosening of the femoral component was found in (b)(6) 2020.The revision surgery was scheduled on (b)(6) 2020.The surgeon exchanged the femoral component and insert.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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 a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.

• Brand Name: LCS COMPLETE FEM CEM R SM+
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10656369
• Report Number: 1818910-2020-21848
• Device Sequence Number: 17032228
• Product Code: NJL
• UDI-Device Identifier: 10603295021537
• UDI-Public: 10603295021537
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1294-01-020
• Device Catalogue Number: 129401020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK KNEE FEMORAL LCS; UNK KNEE TIBIAL INSERT LCS; UNK KNEE FEMORAL LCS; UNK KNEE TIBIAL INSERT LCS
• Outcome Attributed to Adverse Event: Required Intervention