MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE M/B PAT POR LG; LCS COMPLETE : KNEE PATELLA

Catalog Number	129409660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (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 knee was revised on the 16.7.2015 (b)(4) where the femur and insert we replaced with a lg lcs modular revision femur with a 115mm stem and new lg insert.The patella was also resurfaced with a metal backed patella (no implant details available).Patient reported increasing anterior knee pain.Upon revision the femur and tibia were well found to be well fixed and no visible wear on the insert with all 3 components being retained.The patella component was removed with a fair amount of work however came off with a little fibrous in-growth and very little bone.A cemented patella component was reinserted into the knee.
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 code(s) 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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS COMPLETE M/B PAT POR LG
• Common Device Name: LCS COMPLETE : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8682339
• Report Number: 1818910-2019-95530
• Device Sequence Number: 2309140
• Product Code: NJL
• UDI-Device Identifier: 10603295022664
• UDI-Public: 10603295022664
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 129409660
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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 Weight: 95