Persona® The Personalized Knee® 42-5170-003-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00889024238459), received between Feb 13, 2020 and Jun 26, 2024 — classified as 135 malfunctions.

The most frequently reported specific device problem is “Fracture” (134 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 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 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 19616172 ↗
• MalfunctionJun 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TASP BROKE. 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 19468933 ↗
• MalfunctionMay 15, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320941 ↗
• 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 19258415 ↗
• MalfunctionApr 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT A TIBIAL ARTICULAR SURFACE PROVISIONAL INSTRUMENT FRACTURED. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143227 ↗
• MalfunctionApr 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT A TIBIAL ARTICULAR SURFACE PROVISIONAL INSTRUMENT FRACTURED. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143191 ↗
• MalfunctionApr 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT FOLLOWING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE TIBIAL ARTICULAR SURFACE PROVISIONAL INSTRUMENT WAS FOUND TO BE FRACTURED UPON DISASSEMBLY. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041884 ↗
• MalfunctionApr 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE TIBIAL ARTICULAR SURFACE PROVISIONAL INSTRUMENT FRACTURED DURING THE TRIAL PROCESS. NO PATIENT IMPACT OR ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038038 ↗
• MalfunctionApr 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT AN ARTICULAR SURFACE PROVISIONAL FRACTURED DURING TRIALING 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 19014974 ↗
• MalfunctionMar 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING CLEANING OF INSTRUMENTS AFTER SURGERY, THE INSTRUMENT BROKE. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003175 ↗
• MalfunctionMar 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PROVISIONAL FRACTURED 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 18993735 ↗
• MalfunctionMar 27, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987603 ↗
• MalfunctionMar 27, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986555 ↗
• MalfunctionMar 12, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887677 ↗
• 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 18858168 ↗
• MalfunctionFeb 26, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777016 ↗
• MalfunctionFeb 21, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18746797 ↗
• MalfunctionFeb 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TIBIAL ARTICULAR SURFACE PROVISIONAL WAS RETURNED TO ZIMMER BIOMET IN FRACTURED CONDITION. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623551 ↗
• MalfunctionJan 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENTS WERE DISCOVERED FRACTURED DURING AN INSTRUMENT CHECK IN PROCESS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455355 ↗
• MalfunctionDec 19, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354838 ↗
• MalfunctionDec 14, 2023Fracture; Fracture

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

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325372 ↗
• MalfunctionDec 4, 2023Fracture; Difficult to Insert; Fracture; Difficult to Insert

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256014 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE BROKE ON INSERTION. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18254965 ↗
• MalfunctionNov 21, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183571 ↗
• MalfunctionNov 20, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171946 ↗

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-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-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-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-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

…and 24 more.