PERSONA™ 42-5099-093-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00889024232884), received between Mar 2, 2021 and Mar 18, 2026 — classified as 1 injury, 71 malfunctions.

The most frequently reported specific device problem is “Fracture” (72 reports).

39 other recalls cover devices cleared under the same FDA submission (K113369); 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 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Fracture

  IT WAS REPORTED THAT DURING CLEANING OF INSTRUMENTS, A FEMORAL IMPACTOR PAD WAS FOUND FRACTURED. THE CONDITION WAS IDENTIFIED DURING CLEANING. THERE WERE NO MISSING PIECES, AND THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627298 ↗
• MalfunctionMar 4, 2026Fracture

  IT WAS REPORTED THAT THE SURGEON WAS IMPACTING THE FEMORAL IMPLANT AND THE FEMORAL POSTERIOR STABILIZER IMPACTOR PAD BROKE. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. THERE WAS NO DAMAGE TO THE IMPLANT SO THE IMPLANT WAS STILL USED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513034 ↗
• MalfunctionDec 30, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920563 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN DURING AN INITIAL SURGERY. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. ANOTHER DEVICE WAS NOT NEEDED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290561 ↗
• MalfunctionSep 11, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027973 ↗
• MalfunctionSep 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING INSPECTION OF INSTRUMENTS; THE DEVICE WAS FOUND TO BE FRACTURED. THERE WAS NO RELATION TO PROCEDURE OR PATIENT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956453 ↗
• MalfunctionAug 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT AN IMPACTOR PAD FRACTURED DURING FEMORAL IMPLANT INSERTION. 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 22777182 ↗
• MalfunctionAug 4, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700415 ↗
• MalfunctionJul 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE BLUE IMPACTOR BROKE DURING IMPACTION. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372704 ↗
• MalfunctionJun 12, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198273 ↗
• MalfunctionJun 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPACTOR WAS FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131407 ↗
• MalfunctionJun 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPACTOR WAS FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131404 ↗
• MalfunctionJun 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT UPON IMPACTING THE FINAL FEMORAL COMPONENT, THE IMPACTOR PLASTIC BROKE IN THE CORNER. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124231 ↗
• MalfunctionApr 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT A FEMORAL IMPACTOR PAD FRACTURED. 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 21927034 ↗
• InjuryApr 3, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769562 ↗
• MalfunctionMar 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT A FEMORAL IMPACTOR PAD CRACKED WHILE BEING USED FOR IMPLANT IMPACTING. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. THERE WAS NO PATIENT HARM. THE PRODUCT WILL NOT BE RETURNED DUE TO IT WAS DISPOSED BY THE STAFF AFTER PHOTOS WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732995 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THE BLUE PS IMPACTOR PAD BROKE WHEN TRIAL FEMUR WAS BEING PLACED. THERE WAS NO PATIENT HARM OR IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713310 ↗
• MalfunctionMar 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPACTOR PAD BROKE WHILE IMPACTING THE FEMUR. NOTHING FELL INTO THE PATIENT. NO FOREIGN BODIES WERE RETAINED. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536654 ↗
• MalfunctionFeb 20, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420491 ↗
• MalfunctionNov 20, 2024Fracture; Fracture

  IT WAS REPORTED THE FEMORAL IMPACTOR BROKE WHEN TRIAL WAS PLACED ON FEMUR. THERE WAS NO PATIENT IMPACT OR HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737867 ↗
• MalfunctionNov 6, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622648 ↗
• MalfunctionOct 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR BROKE WHILE IMPACTING TRIAL FEMUR. ALL PIECES OF PLASTIC WERE REMOVED. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569194 ↗
• MalfunctionSep 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE PS FEMORAL IMPACTOR BROKE WHILE IMPACTING THE FEMORAL COMPONENT. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20143723 ↗
• MalfunctionSep 3, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130483 ↗
• MalfunctionAug 27, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074776 ↗

Recalls under the same FDA submission

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

• 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-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-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-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-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-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-2575-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM;
• 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.