Persona® The Personalized Knee® 42-5274-005-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024245310), received between Oct 1, 2020 and Mar 13, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT AN ARTICULAR SURFACE 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 18897693 ↗
• MalfunctionMar 5, 2024Fracture; Fracture

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE TIBIAL ARTICULAR SURFACE PROVISIONAL FRACTURED UPON REMOVAL. NO ADDITIONAL INSTRUMENTATION WAS NEEDED AS TRAILING HAD ALREADY BEEN COMPLETED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842202 ↗
• MalfunctionDec 29, 2023Difficult to Insert; Difficult to Insert

  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 18418147 ↗
• MalfunctionOct 11, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916771 ↗
• MalfunctionSep 6, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690259 ↗
• MalfunctionSep 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE 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 17690237 ↗
• MalfunctionSep 6, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690231 ↗
• MalfunctionFeb 15, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16377944 ↗
• MalfunctionJan 31, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273329 ↗
• MalfunctionJan 30, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264479 ↗
• MalfunctionOct 6, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15555616 ↗
• MalfunctionAug 11, 2022Fracture; Fracture

  IT WAS REPORTED DURING AN INITIAL TOTAL RIGHT KNEE PROCEDURE, A TOTAL TIBIAL ARTICULAR SURFACE PROVISIONAL INSTRUMENT FRACTURED WHEN IT WAS BEING EXTRACTED DURING THE TRIAL PROCESS. THERE WAS NO PATIENT IMPACT 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 15209713 ↗
• MalfunctionDec 31, 2020Fracture; Fracture

  NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11101537 ↗
• MalfunctionOct 2, 2020Fracture; Fracture

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. NO SERIOUS INJURY OR HARM TO THE PATIENT REPORTED FOR THIS EVENT OR PRIOR EVENTS WITH SAME OR SIMILAR PRODUCTS. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10620579 ↗
• MalfunctionOct 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT, DURING INSERTION OF THE PROVISIONAL ARTICULAR SURFACE, A LITTLE PIECE OF PLASTIC ON THE BACK SIDE POSTERIOR FRACTURED. ALL THE PIECES HAVE BEEN RETRIEVED. NO HARM TO THE PATIENT AND NO DELAY IN SURGERY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10613436 ↗

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-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-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-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-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-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-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

…and 24 more.