Persona® The Personalized Knee® 42-5270-005-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 234 adverse event reports that list this exact device (DI 00889024245006), received between Dec 17, 2019 and May 15, 2024 — classified as 1 injury, 233 malfunctions.

The most frequently reported specific device problem is “Fracture” (234 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 25 most recent of 234 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT A FRACTURED PROVISIONAL WAS RECEIVED VIA THE WORN INSTRUMENT RETURN PROGRAM. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320776 ↗
• MalfunctionMay 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT A FRACTURED PROVISIONAL WAS RECEIVED FROM A HOSPITAL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280706 ↗
• MalfunctionMay 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258412 ↗
• MalfunctionMay 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258405 ↗
• MalfunctionMay 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT WAS FRACTURED. ALL PIECES WERE RETURNED. THIS ISSUE WAS DISCOVERED DURING A ROUTINE CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229516 ↗
• MalfunctionApr 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE TECHNICIAN OPENED THEL TRAY, THE PROVISIONAL WAS FRACTURED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19107328 ↗
• MalfunctionApr 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT A FRACTURED PROVISIONAL WAS RECEIVED VIA THE WORN INSTRUMENT RETURN PROGRAM. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059231 ↗
• MalfunctionApr 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHILE INSERTING THE TRIAL ARTICULAR SURFACE, THE BASE FRACTURED OFF. ALSO, WHEN CEMENTING IN THE FEMORAL COMPONENT, THE IMPACTOR PAD FRACTURED IN HALF. 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 19035693 ↗
• MalfunctionApr 2, 2024Fracture; Fracture

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS FOUND BROKEN OUTSIDE OF SURGERY. THE REP NOTICED THE DEVICE WAS CRACKED IN THE TRAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020604 ↗
• MalfunctionMar 26, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18982083 ↗
• MalfunctionMar 22, 2024Fracture; Fracture

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE TIBIAL ARTICULAR SURFACE PROVISIONAL FRACTURED UPON INSERTION. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959597 ↗
• MalfunctionMar 21, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951741 ↗
• MalfunctionMar 7, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858207 ↗
• MalfunctionMar 7, 2024Fracture; Fracture

  IT WAS REPORTED A TASPS WERE RETURNED FRACTURED ON A WORN INSTRUMENT CLAIM FORM. ALL PIECES HAVE NOT BEEN RETURNED. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858202 ↗
• MalfunctionMar 7, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858196 ↗
• MalfunctionMar 5, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836407 ↗
• MalfunctionMar 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PROVISIONAL FRACTURED DURING A KNEE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836002 ↗
• MalfunctionMar 5, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835735 ↗
• MalfunctionFeb 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PROVISIONAL FRACTURED AFTER BEING STRUCK WITH A MALLET DURING INSERTION INTO THE JOINT SPACE AS PART OF A KNEE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18731176 ↗
• MalfunctionFeb 9, 2024Fracture; Fracture

  IT WAS REPORTED THE INSTRUMENT BROKE WHILE TRAILING. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676281 ↗
• MalfunctionFeb 7, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT A TASP WAS WORN TO A POINT IT WAS UNABLE TO BE USED BUT WAS LATER FOUND TO BE FRACTURED. NO DEBRIS FELL OR WAS LEFT IN THE PATIENT. 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 18661458 ↗
• MalfunctionFeb 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18661231 ↗
• InjuryFeb 1, 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 18623539 ↗
• MalfunctionJan 31, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614876 ↗
• MalfunctionJan 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT BROKE WHEN INSERTING. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. ANOTHER DEVICE WAS NOT NEEDED TO COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563580 ↗

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-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-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-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-2578-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 m
• 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-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

…and 24 more.