Prolong® NexGen® 5952-40-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024208018), received between Aug 28, 2019 and Oct 23, 2024 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 reports).

67 other recalls cover devices cleared under the same FDA submission (K003910, K013991, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOUR YEARS AND THREE MONTHS POST IMPLANTATION DUE TO INSTABILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517946 ↗
• MalfunctionJan 3, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437292 ↗
• MalfunctionNov 20, 2023Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169809 ↗
• MalfunctionJun 2, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT HAD A LARGE FUSION AND THERE IS SOME INCREASED BONE FORMATION AND METAPHYSIS AT THE JUNCTION OF THE PROSTHESIS ON THE FEMORAL SIDE. THERE IS ALSO SOME ECTOPIC ANTERIOR BONE OVER THE PATELLA. IT WAS NOTED THAT THIS MAY BE ATTRIBUTED TO POLYETHYLENE WEAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Extraskeletal ossification; Swelling/ Edema

  MAUDE report 14572714 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Damage to Ligament(s)

  MAUDE report 11976655 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 11462543 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE MUA APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO ARTHROFIBROSIS.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 11460130 ↗
• InjuryJul 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Information

  MAUDE report 10332929 ↗
• InjuryJun 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS STIFFNESS NEARLY FOURTEEN (14) MONTHS POST-OPERATIVELY. ALL COMPONENTS WERE REMOVED AND REPLACED EXCEPT FOR THE PATELLAR COMPONENT. ATTEMPTS ARE BEING MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion

  MAUDE report 10123186 ↗
• MalfunctionMay 20, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A HAIR WAS FOUND ON THE STERILE ART SURFACE BEFORE INSERTION. THE NURSES NOTICED A HAIR ON THE STERILE BEARING WHEN OPENING THE STERILE PACKAGING. ALL NURSES AND SURGEONS WERE WEARING STERILE SPACE SUITE GOWNS AT THE TIME. THE HAIR WAS LOCATED ON THE ART SURFACE AS PER ATTACHED PICTURE. THE ART SURFACE WAS HANDED OFF AND FORTUNATELY THERE WAS A SECOND SET ONSITE SO A REPLACEMENT WAS USED FROM THAT SET. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10074022 ↗
• MalfunctionMar 16, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL TKA, THE ARTICULAR SURFACE FAILED TO ENGAGE WITH THE TIBIAL TRAY DURING INSERTION. THE SURGEON ATTEMPTED TO FREE-HAND IMPACT THE ARTICULAR SURFACE AND WHEN THAT FAILED, HE HAD ATTEMPTED TO USE THE INSERTION INSTRUMENT. AT THIS POINT, THE DEVICE WAS ALREADY DEFORMED FROM THE ATTEMPTS AND WOULD NOT LOCK INTO PLACE. AN ARTICULAR SURFACE IN THE NEXT SIZE UP WAS USED AND SUCCESSFULLY IMPLANTED. THERE WAS NO IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9836558 ↗
• InjuryNov 27, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY TWO YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO TIBIAL AND ARTICULAR SURFACE LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9386625 ↗
• InjuryAug 28, 2019Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Infiltration into Tissue; No Code Available

  MAUDE report 8939074 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003910, K013991, 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-1551-2012 · Feb 24, 2012 · Terminated
  00595202020, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface Size Purple/A E Micro 20 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw,
• Z-1586-2012 · Feb 24, 2012 · Terminated
  REF 00-5972-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 12mm Height , Steril
• Z-1596-2012 · Feb 24, 2012 · Terminated
  REF 00-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 20 mm Height , Steri
• Z-1567-2012 · Feb 24, 2012 · Terminated
  90-5970-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 17mm Height , Use With Plate 1,2 Sterile R,
• Z-1572-2012 · Feb 24, 2012 · Terminated
  00-5972-020-14, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 14 mm Height , Sterile R, Rx ,Zimmer, Inc. W
• Z-1561-2012 · Feb 24, 2012 · Terminated
  00-5970-020-17, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 17 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Kne
• Z-1549-2012 · Feb 24, 2012 · Terminated
  00595202014, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 14mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, I
• Z-1593-2012 · Feb 24, 2012 · Terminated
  REF 00-5970-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 12mm Height , Steril
• Z-1602-2012 · Feb 24, 2012 · Terminated
  90-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 20 mm Height
• Z-1548-2012 · Feb 24, 2012 · Terminated
  00595202012, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 12mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, I
• Z-1603-2012 · Feb 24, 2012 · Terminated
  REF 00-5972-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 20mm Heig
• Z-1585-2012 · Feb 24, 2012 · Terminated
  REF 00-5972-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 10mm Height , Steril
• Z-1606-2012 · Feb 24, 2012 · Terminated
  00-5976-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 14 mm Height , Steril

…and 52 more.