Gender Solutions® Natural-Knee® Prolong® 00-5428-011-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024190467), received between Jun 2, 2022 and Jun 2, 2022 — classified as 1 injury.

65 other recalls cover devices cleared under the same FDA submission (K070214, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY AND PRESCRIBED MEDICATION TWO DAYS POST-OP. SUBSEQUENTLY, APPROXIMATELY A WEEK LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ATRIAL FIBRILLATION AND A PULMONARY EMBOLISM. THE ISSUES WERE RESOLVED BY THE FOLLOWING DAY WITH NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Atrial Fibrillation; Pulmonary Embolism

  MAUDE report 14577366 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070214, 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-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-0207-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 16 MM height, for use with baseplate size 1 or 2 sterile, Zimmer, Warsaw, I
• Z-0200-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 11 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN;
• Z-0223-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw,
• Z-0220-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 11 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw,
• Z-0229-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 9 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, War
• Z-0204-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 9 MM height, use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; RE
• Z-0239-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 9 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer,
• Z-0217-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 16 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw
• Z-0225-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 11 MM height, for use with baseplate size 3, 4, or 5, sterile, Zimmer, Wa
• Z-0208-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 19 MM height, for use with baseplate size 1 or 2 sterile, Zimmer, Warsaw, I
• Z-0245-2010 · Oct 8, 2009 · Terminated
  Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 11 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, W

…and 50 more.