MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMP RPSFLEX FEM CEM L LG+; KNEE FEMORAL

Model Number	1294-12-070
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loose or Intermittent Connection (1371); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Distress (2329); Discomfort (2330); Injury (2348); Joint Disorder (2373); No Code Available (3191)
Date of Event	08/29/2017
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
Patient initiated form received.It was reported that the patient was revised due to so much pain and suffering.Doi: (b)(6) 2012: dor: (b)(6) 2017 (left knee).
Event or Problem Description
Revision to address loosening of the tibial and femoral components, pain and swelling.
Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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 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. .
Event or Problem Description
Litigation record received.Litigation alleges pain, injury, swelling, stiffness, weakness, discomfort, emotional distress and effusion in the left knee with documented infection.It was also confirmed that the indication for surgery was "the left tkr with aseptic loosening of the femoral and tibial components.".
Additional 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.Device history lot - null.Device history batch - null.Device history review - null.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.  h10 additional narrative:  added a2, h6.Corrected b4.H6 patient code: no code available (3191) used to capture the surgical intervention.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary update 5-nov-2020: the investigation was re-opened upon receipt of additional information.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.

• Brand Name: LCS COMP RPSFLEX FEM CEM L LG+
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7141847
• Report Number: 1818910-2017-52438
• Device Sequence Number: 901478
• Product Code: NJL
• UDI-Device Identifier: 10603295022954
• UDI-Public: 10603295022954
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/08/2019

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 Expiration Date: 03/01/2022
• Device Model Number: 1294-12-070
• Device Catalogue Number: 129412070
• Device Lot Number: 3428880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/22/2018; 05/07/2018; 01/24/2019; 08/08/2019; 11/17/2020
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 02/21/2018; 05/08/2018; 02/20/2019; 08/28/2019; 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR