PERSONA® 42-5000-064-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024228788), received between Aug 28, 2019 and May 11, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Unstable” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ABOUT 2 YEARS TWO MONTHS POST PROCEDURE THE PATIENT FELL FOR UNKNOWN REASONS, CAUSING PAIN AND SWELLING. PATIENT WAS SEEN IN THE OFFICE WHERE KNEE WAS ASPIRATED WITHOUT COMPLICATION.

  Patient problems: Fall; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 16913357 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 1 WEEK POST OP, THE PATIENT PRESENTS TO AN OFFICE APPOINTMENT WITH COMPLAINTS OF INCREASING PAIN SINCE PLACING WEIGHT ON POST-OP DAY 1, LEADING TO THE PATIENT NOW BEING UNABLE TO BEAR WEIGHT ON THE RIGHT LOWER EXTREMITY. ON RADIOGRAPHIC IMAGING, A DISPLACED MEDIAL CONDYLE FEMORAL FRACTURE AND LOOSENING OF THE TIBIAL STEM WERE IDENTIFIED. 10 DAYS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION OF ALL COMPONENTS, EXCEPT THE PATELLA, WITHOUT COMPLICATION.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Failure of Implant; Osteopenia/ Osteoporosis; Pain

  MAUDE report 16674199 ↗
• InjuryDec 13, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED PATIENT UNDERWENT ARTHROSCOPIC SYNOVECTOMY POST IMPLANTATION DUE TO PATELLAR CLUNK SYNDROME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Scar Tissue

  MAUDE report 15968908 ↗
• InjurySep 1, 2021Unstable; Unstable

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

  Patient problems: Pain

  MAUDE report 12409173 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Blood Loss; Bone Fracture(s)

  MAUDE report 10573018 ↗
• InjurySep 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED PATIENT HAD AN IRRIGATION AND DEBRIDEMENT WITH REMOVAL OF THE POLY APPROXIMATELY 15 DAYS POST IMPLANTATION DUE TO AN INFECTION AND WOUND DEHISCENCE. THE FOLLOWING DAY ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED ALONG WITH AN IM NAIL. THE PATIENT WAS POSITIVE FOR STAPH EPIDERMIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Bacterial Infection; Hematoma; Loss of Range of Motion; Necrosis; Tissue Damage; Wound Dehiscence

  MAUDE report 10573011 ↗
• InjuryOct 29, 2019Unstable; Unstable

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

  Patient problems: Inflammation; Pain; Patient Problem/Medical Problem; Swelling

  MAUDE report 9252142 ↗
• InjuryAug 28, 2019Unstable; Unstable

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT IS EXPERIENCING PAIN, SWELLING, LOCKING UP AND LOOSENING. A REVISION PROCEDURE HAS BEEN INDICATED; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

  Patient problems: Pain; Swelling

  MAUDE report 8942182 ↗

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-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-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-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-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
• 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-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.