Persona® The Personalized Knee® 42-5279-005-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024245860), received between Feb 5, 2020 and Aug 18, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (23 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.

• MalfunctionAug 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50300236 ↗
• MalfunctionAug 17, 2026Component Missing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50288333 ↗
• MalfunctionJul 28, 2026Detachment of Device or Device Component

  It was reported that a disassembled shim was returned. There was no patient involvement. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063551 ↗
• MalfunctionMay 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALL BEARING OF A SHIM POPPED OUT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218455 ↗
• MalfunctionMay 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHIM EF WAS FOUND TO HAVE A MISSING BALL BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184071 ↗
• MalfunctionJan 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROVISIONAL SHIM INSTRUMENT WAS FOUND TO BE DISASSEMBLED AND MISSING BALL BEARINGS DURING TRAY INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992288 ↗
• 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 23279111 ↗
• MalfunctionAug 12, 2025Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  IT WAS REPORTED THE BALL BEARINGS WERE MISSING FROM E-F 12MM. NO PATIENT HARM OR IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783017 ↗
• MalfunctionJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSTRUMENTS WERE RETURNED MISSING BEARINGS ON A WORN INSTRUMENT CLAIM FORM. IT WAS NOTED THEY WERE RETURNED TO THE WAREHOUSE IN THIS CONDITION AFTER WASHING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183387 ↗
• MalfunctionOct 23, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THE INSTRUMENT WAS RETURNED FRACTURED AND DISASSEMBLED ON A WORN INSTRUMENT CLAIM FORM. NOT ALL PIECES WERE RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517336 ↗
• MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING CLEANING, THE STERILIZATION STAFF NOTICED THAT THE SHIMS WERE MISSING A BEAD. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291207 ↗
• MalfunctionMar 26, 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 18977960 ↗
• MalfunctionMar 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE INSTRUMENT WAS RETURNED MISSING BEARINGS ON A WORN INSTRUMENT CLAIM FORM. THERE WAS NO KNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552694 ↗
• MalfunctionMar 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE INSTRUMENT WAS RETURNED MISSING BEARINGS ON A WORN INSTRUMENT CLAIM FORM. THERE WAS NO KNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552677 ↗
• MalfunctionMar 16, 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 16552674 ↗
• MalfunctionMar 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE INSTRUMENT WAS RETURNED MISSING BEARINGS ON A WORN INSTRUMENT CLAIM FORM. THERE WAS NO KNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552672 ↗
• MalfunctionMar 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE INSTRUMENT WAS RETURNED MISSING BEARINGS ON A WORN INSTRUMENT CLAIM FORM. THERE WAS NO KNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552658 ↗
• MalfunctionMar 16, 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 16552565 ↗
• MalfunctionMar 14, 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 16536864 ↗
• MalfunctionFeb 13, 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 16362893 ↗
• MalfunctionOct 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO INSTRUMENTS WERE RETURNED MISSING BEARINGS. THE INSTRUMENTS WERE DISCOVERED AFTER COMING OUT OF SPD. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527079 ↗
• MalfunctionFeb 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SHIMS WERE MISSING BEARINGS. THE INSTRUMENTS WERE DISCOVERED OUTSIDE OF THE OPERATING ROOM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345396 ↗
• MalfunctionFeb 5, 2020Detachment 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 Patient Involvement

  MAUDE report 9670855 ↗
• MalfunctionFeb 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A KNEE INSTRUMENT WAS FOUND DISASSEMBLED AT THE BOTTOM OF THE ULTRASONIC CLEANER. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 9670838 ↗

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-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-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-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-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-2576-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 E
• 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-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.