PERSONA® 42-5000-064-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024228771), received between Oct 29, 2019 and Jun 4, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. PATIENT REPORTED A POPPING SENSATION WITH FEELING THE JOINT GAVE OUT. THEY NOTED THEIR LAST EPISODE THEY HEARD THE POP AND FELT THE IMPLANT MOVE OUT THEN POP INTO PLACE. THE PATIENT ALSO REPORTED HAVING PAIN AND DIFFICULTY AMBULATING. NO RECORDS WERE PROVIDED. THE PATIENT FOLLOWED UP WITH THEIR SURGEON, WHO ORDERED AN MRI FOR THEIR CONTINUED PAIN, DIFFICULTY AMBULATING, DECREASED RANGE OF MOTION, AND SUBLUXATION. A REVISION WAS PLANNED FOR THE NEAR FUTURE BUT WAS DELAYED DUE TO THE PATIENT'S MEDICAL HISTORY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Subluxation; Swelling/ Edema

  MAUDE report 19461964 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Muscle/Tendon Damage; Pain; Synovitis

  MAUDE report 17894281 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROSCOPY APPROXIMATELY SEVEN (7) MONTHS POST-OPERATIVELY TO ADDRESS PATELLAR CLUNK AND A CATCHING FEELING. DURING THE ARTHROSCOPY, SYNOVITIS AND FIBROUS TISSUE AT THE SUPERIOR POLE OF THE PATELLA WERE IDENTIFIED AND APPEARED TO BE ENGAGING WITH THE BOX OF THE FEMUR AND WAS SCARRED THROUGH THE MEDIAL GUTTER. A SYNOVECTOMY WAS PERFORMED, AND SCAR TISSUE WAS REMOVED WITHOUT COMPLICATION. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue; Synovitis

  MAUDE report 16714420 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS APPROXIMATELY THREE (3) MONTHS FOLLOWING LEFT KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 16686405 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS WORSENING PAIN, INCREASING FUNCTIONAL LIMITATIONS AND INSTABILITY APPROXIMATELY ONE YEAR POST-OPERATIVELY. REVISION OPERATIVE NOTES NOTED THE PATELLAR COMPONENT WAS EXAMINED TO BE STABLE AND REMAINED IMPLANTED. REMOVAL OF THE FEMORAL AND TIBIAL COMPONENTS SHOWED MINIMAL BONE LOSS. APPROPRIATE RANGE OF MOTION, STABILITY AND PATELLAR TRACKING WERE ACHIEVED WITH NEW COMPONENTS. NO INTRAOPERATIVE COMPLICATIONS WERE IDENTIFIED AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14653313 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Embolism/Embolus

  MAUDE report 12960402 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 12267812 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 11231183 ↗
• InjuryOct 29, 2019Unstable; Unstable

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

  Patient problems: Inflammation; Pain; Swelling

  MAUDE report 9252277 ↗

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-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-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-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-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-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;
• 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-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

…and 24 more.