Persona® The Personalized Knee® 42-5279-005-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024245846), received between Dec 27, 2022 and Oct 15, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (24 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279270 ↗
• MalfunctionSep 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE CHECKING THE TRAYS, THE SALES REP DISCOVERED THE SHIMS MISSING BEARINGS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073036 ↗
• MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT INSTRUMENTS WERE RETURNED MISSING BEARINGS ON A WORN INSTRUMENT CLAIM FORM. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057656 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM WAS IDENTIFIED TO BE MISSING THE BALL BEARINGS WHEN IT WAS RETURNED TO THE DISTRIBUTORSHIP WAREHOUSE AFTER STERILIZATION. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642255 ↗
• MalfunctionApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898668 ↗
• MalfunctionMar 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT AS REPORTED THE BALL BEARINGS CAME OUT DURING SONIC CLEANING OF THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708789 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TASP SHIM WAS RETURNED MISSING BEARINGS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305031 ↗
• MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091697 ↗
• MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091692 ↗
• MalfunctionNov 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20728213 ↗
• MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20460170 ↗
• MalfunctionSep 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189495 ↗
• MalfunctionJun 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROVISIONAL SHIM MISSING A BALL BEARING WAS RECEIVED VIA THE WORN INSTRUMENT RETURN PROGRAM. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481313 ↗
• MalfunctionMay 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19414161 ↗
• MalfunctionMay 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TASP SHIM WAS RETURNED MISSING BEARINGS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320922 ↗
• MalfunctionApr 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143467 ↗
• MalfunctionOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038074 ↗
• MalfunctionOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038057 ↗
• MalfunctionAug 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INVENTORY, BOTH BALL BEARINGS HAVE FALLEN OUT OF THE INSTRUMENT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653027 ↗
• MalfunctionAug 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595748 ↗
• MalfunctionApr 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE BALL BEARING WAS LOST DURING WASHING PROCESS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776318 ↗
• MalfunctionJan 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16186249 ↗
• MalfunctionJan 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE WAS DISCOVERED TO HAVE MISSING COMPONENTS. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137802 ↗
• MalfunctionDec 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE WAS DISCOVERED TO HAVE MISSING COMPONENTS. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16055355 ↗

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-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
• 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;

…and 24 more.