PERSONA® 42-5299-001-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00889024246423), received between Jul 1, 2020 and Jun 24, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 reports).

39 other recalls cover devices cleared under the same FDA submission (K113369, K172524); 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Fracture

  IT WAS REPORTED THAT THE BOTTOM PORTION OF THE INSTRUMENT SHEARED OFF DURING POLYETHYLENE INSERTION, PREVENTING ENGAGEMENT WITH THE TIBIAL BASE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25607343 ↗
• MalfunctionNov 13, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543053 ↗
• MalfunctionApr 2, 2025Fracture; Fracture

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE ARTICULAR SURFACE INSERTER TIP FRACTURED UPON INSERTION OF THE ARTICULAR SURFACE. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752876 ↗
• MalfunctionMar 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE TIP OF THE ARTICULAR SURFACE INSERTER FRACTURED DURING INSERTION OF THE BEARING. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702258 ↗
• MalfunctionNov 22, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756742 ↗
• MalfunctionOct 3, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358662 ↗
• MalfunctionFeb 27, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789585 ↗
• MalfunctionNov 29, 2023Fracture; Fracture

  IT WAS REPORTED THE POLY INSERTER TIP BROKE DURING THE PROCEDURE. THERE WAS NO PATIENT HARM OR IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18232445 ↗
• MalfunctionOct 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT A FRACTURED INSTRUMENT WAS DISCOVERED DURING A KNEE PROCEDURE. IT IS UNKNOWN WHEN THE DEVICE FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038692 ↗
• MalfunctionOct 9, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894364 ↗
• MalfunctionAug 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE FRACTURED AND THIS RESULTED IN THAT THE IMPLANTS DROPPING TO THE FLOOR DURING PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652129 ↗
• MalfunctionOct 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE FRACTURED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605640 ↗
• MalfunctionSep 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TOP OF THE INSERTER FRACTURED DURING FINAL INSERTION. THE ARTICULAR SURFACE WAS INSERTED FULLY, AND THE INSERTER WAS NOT NEEDED ANYMORE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519867 ↗
• MalfunctionAug 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHILE PREPPING THE INSTRUMENT CASE FOR KNEE ARTHROPLASTY AT THE BACK TABLE, THE ARTICULAR SURFACE INSERTER WAS IDENTIFIED TO HAVE FRACTURED. ANOTHER ARTICULAR SURFACE INSERTER WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302855 ↗
• MalfunctionAug 16, 2022Fracture; Fracture

  IT WAS REPORTED THE TIP OF THE FORCEPTS FRACTURED OFF. THE FRACTURED PIECE WAS DISCARDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15238106 ↗
• MalfunctionJun 27, 2022Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT AN INSTRUMENT IS JAMMED AND FRACTURED. THE INSTRUMENT THAT CLIPS UNDER THE TIP OF THE INSTRUMENT GETS STUCK ONCE IT IS INSTALLED ON IT. IT DOES NOT MOVE FROM ONE SIDE TO THE OTHER ONCE IT IS CLIPPED. THE MECHANISM THAT HOLDS ON THE INSTRUMENT IS FRACTURED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830406 ↗
• MalfunctionJun 27, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE COMPONENT WOULD NOT PROPERLY SEAT ON THE TIBIAL TRAY. THERE WAS NO SURGICAL DELAY OR PATIENT IMPACT. THE SURGERY WAS COMPLETED WITH A SECOND IMPLANT WITHOUT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14829503 ↗
• MalfunctionMay 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN INSTRUMENT FRACTURED. THE SURGEON WAS UNABLE TO INSERT THE ARTICULAR SURFACE WITH THE INSTRUMENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434193 ↗
• MalfunctionSep 14, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471712 ↗
• MalfunctionSep 14, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471695 ↗
• MalfunctionJul 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT FRACTURED DURING POLY INSERTION AS PART OF A KNEE REVISION PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10218930 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113369, K172524. One submission often covers many models, so check the product and lot details in each record.

• Z-1808-2018 · Aug 7, 2017 · Terminated
  Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.
• Z-1805-2018 · Aug 7, 2017 · Terminated
  Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
• Z-1807-2018 · Aug 7, 2017 · Terminated
  Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
• Z-1806-2018 · Aug 7, 2017 · Terminated
  Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
• Z-1340-2016 · Mar 17, 2016 · Terminated
  Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14
• Z-1341-2016 · Mar 17, 2016 · Terminated
  Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18
• Z-1157-2016 · Jan 11, 2016 · Terminated
  Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL
• Z-1360-2015 · Mar 10, 2015 · Terminated
  Brand Name: Persona Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthrop
• Z-0853-2015 · Dec 4, 2014 · Terminated
  Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA p
• Z-1042-2015 · Nov 25, 2014 · Terminated
  Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
• Z-0198-2015 · Oct 9, 2014 · Terminated
  Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, t
• Z-0123-2015 · Oct 7, 2014 · Terminated
  The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the
• Z-2577-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12
• Z-2579-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6
• Z-2580-2014 · Aug 7, 2014 · Terminated
  PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3

…and 24 more.