NexGen® Legacy® 5996-17-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024001541), received between Sep 16, 2020 and May 2, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

35 other recalls cover devices cleared under the same FDA submission (K173057, K960279, P060037); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE ARE NO ALLEGATIONS AGAINST THIS DEVICE. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Insufficient Information

  MAUDE report 21950917 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING PAIN AND FAILED TO PROGRESSIVELY INCREASE RANGE OF MOTION AS EXPECTED WITH PHYSICAL THERAPY. APPROXIMATELY 6 WEEKS POST IMPLANTATION, A MANIPULATION UNDER ANESTHESIA WAS COMPLETED WITH LYSIS OF ADHESIONS AND SUCCESSFUL RETURN TO AN APPROPRIATE DEGREE OF RANGE OF MOTION. ALL INITIAL COMPONENTS WERE RETAINED.

  Patient problems: Adhesion(s); Arthrofibrosis; Loss of Range of Motion; Pain

  MAUDE report 21925329 ↗
• InjurySep 16, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION TWO MONTHS AGO AFTER UNDERGOING AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY FOUR YEARS PRIOR, DUE TO PAIN AND LOOSENING OF THE TIBIAL PLATE AND FEMORAL COMPONENT. THE PATIENT HAD TO LIMIT ACTIVITIES DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 10540584 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173057, K960279, P060037. One submission often covers many models, so check the product and lot details in each record.

• Z-1038-2025 · Jan 6, 2025 · Open, Classified
  NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
• Z-1039-2025 · Jan 6, 2025 · Open, Classified
  NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
• Z-2092-2023 · May 19, 2023 · Terminated
  NexGen Precoat Stemmed Tibial Plate Size 5
• Z-0321-2020 · Oct 10, 2019 · Terminated
  Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
• Z-0324-2020 · Oct 10, 2019 · Terminated
  LPS-MOB ART SURF IMPL D 9MM
• Z-1044-2018 · Nov 29, 2017 · Terminated
  LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FL
• Z-1036-2018 · Nov 29, 2017 · Terminated
  LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L
• Z-1045-2018 · Nov 29, 2017 · Terminated
  NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability
• Z-1043-2018 · Nov 29, 2017 · Terminated
  LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPT
• Z-1035-2018 · Nov 29, 2017 · Terminated
  LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R LPS OPTION FEMORAL F-L LPS OPTION FEMORAL
• Z-1037-2018 · Nov 29, 2017 · Terminated
  LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMPLANT SZ F-L LCCK FEM IMPLANT SZ F-R This device
• Z-1038-2018 · Nov 29, 2017 · Terminated
  LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability
• Z-1034-2018 · Nov 29, 2017 · Terminated
  LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability
• Z-1040-2018 · Nov 29, 2017 · Terminated
  LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and disability
• Z-0663-2018 · Jul 24, 2017 · Terminated
  NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.

…and 20 more.