PERSONA® 42-5006-066-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024229259), received between Oct 23, 2020 and Aug 27, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Laxity; Periprosthetic fracture

  MAUDE report 22902070 ↗
• InjuryMay 13, 2025Adverse 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; Pain; Synovitis

  MAUDE report 22008832 ↗
• InjuryDec 13, 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 ARTHROPLASTY REVISION TO ADDRESS FLEXION/EXTENSION INSTABILITY APPROXIMATELY FOUR (4) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 18322755 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA TWO MONTHS POST IMPLANTATION DUE TO ARTHROFIBROSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain

  MAUDE report 17171088 ↗
• InjuryApr 5, 2023Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TEN MONTHS POST IMPLANTATION DUE TO LOOSENING, PAIN, NOISE, BURNING SENSATION, INSTABILITY, AND LIMITED ROM. DURING THE SECOND REVISION THE SURGEON NOTED SCAR TISSUE AND THE IMPLANT WAS NOT IN CORRECT POSITION, CONFIRMED LOOSENING OF TIBIA, AND TIBIAL IMPLANT WAS GRINDING ON SURROUNDING BONE. THE TIBIA, FEMUR, AND ARTICULATING SURFACE WERE EXCHANGED, AND THE CERCLAGE CABLES WERE REMOVED WITHOUT COMPLICATIONS. THE PATELLA WAS WELL FIXED AND REMAINED IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Erosion; Failure of Implant; Loss of Range of Motion; Pain; Scar Tissue; Skin Burning Sensation

  MAUDE report 16681127 ↗
• InjurySep 30, 2021Material Erosion; Naturally Worn; Material Erosion; Naturally Worn

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT FELT A POP IN THE KNEE THREE WEEKS BEFORE THE REVISION SURGERY. PATIENT WAS THEN REVISED 2 YEARS AND 9 MONTHS POST IMPLANTATION DUE TO PAIN. PRE-REVISION IMAGES SHOWED THAT THE FEMUR AND TIBIA COMPONENTS WERE IN CONTACT WITH EACH OTHER AND THE ARTICULAR SURFACE COULD NOT BE SEEN. DURING THE REVISION SURGERY, THE ARTICULAR SURFACE WAS FOUND TO BE BROKEN INTO TWO PIECES AND NO LONGER HINGED ONTO THE TIBIA LOCKING MECHANISM. PATIENT¿S KNEE WAS ALSO SEEN TO HAVE METALLOSIS IN THE JOINT, AND THE FEMUR AND TIBIA IMPLANTS BOTH HAVE VISIBLE WEARS. PATIENT WAS REVISED TO A ROTATING HINGE KNEE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Local Reaction; Metal Related Pathology; Pain

  MAUDE report 12556267 ↗
• InjuryMar 29, 2021Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT JOINT ASPIRATIONS AND ARTHROSCOPIC DEBRIDEMENT DUE TO SWELLING, SYNOVITIS, AND ADHESIONS AFTER UNDERGOING AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. THE PATIENT WAS REVISED APPROXIMATELY ONE YEAR AND ELEVEN MONTHS¿ POST IMPLANTATION DUE TO LOOSENING. DURING THE REVISION, THE SURGEON NOTED THAT THE BONE AROUND THE FEMUR WAS SIGNIFICANTLY SOFTENED AND ALMOST LIQUEFIED AND THERE WERE MULTIPLE CYSTS PRESENT UNDER THE PATELLAR IMPLANT. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Adhesion(s); Cyst(s); Erosion; Failure of Implant; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 11582724 ↗
• InjuryOct 23, 2020Noise, Audible; Noise, Audible

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

  Patient problems: Ambulation or Postural Difficulties; Nerve Damage; Pain; Swelling; Synovitis

  MAUDE report 10726892 ↗

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-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-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-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-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-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;

…and 24 more.