Gender Solutions® Natural-Knee® Prolong® 00-5420-008-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024189607), received between Nov 26, 2019 and Jan 27, 2023 — classified as 2 injuries.

73 other recalls cover devices cleared under the same FDA submission (K070214, K071107, K073286, K173057); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Pulmonary Embolism

  MAUDE report 16254723 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTS EXPERIENCING PAIN, SWELLING, AND TENDERNESS IN THE LEFT KNEE APPROXIMATELY ONE YEAR POST KNEE ARTHROPLASTY. FLUID HAS BEEN DRAINED FROM THE KNEE THREE TIMES. PATIENT REPORTED AN ADDITIONAL KNEE ASPIRATION AND CONTINUED PAIN AND DISCOMFORT WITH THEIR KNEE, ESPECIALLY WHEN DESCENDING STAIRS, SITTING, AND STANDING.

  Patient problems: Ambulation or Postural Difficulties; Aspiration/Inhalation; Pain; Swelling

  MAUDE report 9378835 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070214, K071107, K073286, K173057. One submission often covers many models, so check the product and lot details in each record.

• 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-1058-2018 · Nov 29, 2017 · Terminated
  CR-FLEX GSF PCT SZ C-R MINUS CR-FLEX GSF PCT SZ D-L MINUS CR-FLEX GSF PCT SZ D-R MINUS CR-FLEX GSF PCT SZ E-L MINUS CR-FLEX GSF PCT SZ E-R MINUS CR-FLEX GSF PCT SZ F-L MINUS CR-FLE
• Z-1059-2018 · Nov 29, 2017 · Terminated
  CR-FLEX GSF PRECOAT SZ C-L CR-FLEX GSF PRECOAT SZ C-R CR-FLEX GSF PRECOAT SZ D-L CR-FLEX GSF PRECOAT SZ D-R CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R CR-FLEX GSF PRECOA
• Z-1061-2018 · Nov 29, 2017 · Terminated
  GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT
• Z-1060-2018 · Nov 29, 2017 · Terminated
  GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM
• Z-0838-2016 · Jan 11, 2016 · Terminated
  CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constraine
• Z-2585-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is
• Z-2583-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing
• Z-2582-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is
• Z-2584-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing i
• Z-1248-2014 · Feb 25, 2014 · Terminated
  Gender Solutions" Natural-Knee Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT
• Z-0219-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1 or 2, right, 9 MM height, for use with baseplate size 1, 2, sterile, Zimmer, Warsaw,
• Z-0222-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 16 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw,
• Z-0242-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 16 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer,

…and 58 more.