PERSONA® 42-5020-060-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024229891), received between Apr 17, 2019 and Sep 28, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bone Fracture(s); Damage to Ligament(s)

  MAUDE report 50919300 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 6 MONTHS BEFORE THE PATIENT REPORTED EXPERIENCING A POPPING SENSATION. ON EVALUATION, THE PATIENT DEMONSTRATED GOOD STABILITY, BALANCE, AND APPROPRIATE PATELLAR TRACKING. THE PATIENT WAS DIAGNOSED WITH PATELLAR TENDINITIS, PES ANSERINE BURSITIS, AND ILIOTIBIAL BAND INSERTIONAL TENDERNESS. TREATMENT INCLUDED A LEFT BURSA INJECTION AND A LEFT ILIOTIBIAL BAND INJECTION. THE PATIENT WAS ALSO INSTRUCTED TO APPLY A TOPICAL ANTI-INFLAMMATORY CREAM AND WAS PROVIDED WITH A COMPRESSION STOCKING. THERE WERE NO CONCERNS OR ALLEGATIONS REGARDING THE IMPLANTED COMPONENTS, WHICH REMAIN IN PLACE. THE EVENT HAS BEEN REPORTED AS RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Discomfort; Tendinopathy

  MAUDE report 24955053 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN, LOSS OF FLEXION AND MOBILITY, AND WAS FOUND TO HAVE A NICKEL ALLERGY. APPROXIMATELY 3.5 YEARS POST-OP, THE PATIENT UNDERWENT A REVISION TO NICKEL FREE IMPLANTS. THE FEMORAL COMPONENT AND BEARING WERE REVISED. THE SURGEON NOTED THAT THE FEMORAL COMPONENT WAS WHAT CONTAINED NICKEL.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 23535503 ↗
• InjuryJan 31, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 21283928 ↗
• InjuryJan 2, 2025Adverse 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. APPROXIMATELY 56 DAYS POST IMPLANTATION, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO DECREASED RANGE OF MOTION. HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 21060813 ↗
• InjuryDec 10, 2024Adverse 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: Thrombosis/Thrombus

  MAUDE report 20891800 ↗
• InjurySep 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO LOOSENING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 20281214 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN, SWELLING, DAMAGED NERVE AND RANGE OF MOTION POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Nerve Damage; Pain; Swelling/ Edema

  MAUDE report 16585947 ↗
• MalfunctionJan 11, 2023Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16139671 ↗
• InjuryApr 22, 2020Fracture; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT KNEE PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2019. SUBSEQUENTLY, THE PATIENT REPORTS SWELLING, INSTABILITY, AND THAT A BONE SCAN SHOWS LOOSENING. THE PATIENT TESTED POSITIVE FOR A SENSITIVITY TO NICKEL. NO REVISION PROCEDURE WAS REPORTED.

  Patient problems: Damage to Ligament(s); Pain; Reaction; Swelling

  MAUDE report 9988310 ↗
• InjuryApr 22, 2020Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY SIX MONTHS LATER, FOLLOWING MORE CONSERVATIVE APPROACHES TO ADDRESS INSTABILITY, THE TENDON WAS RELEASED AND THE TIBIAL INSERT WAS REPLACED WITH A MORE STABILIZING VERSION.

  Patient problems: Loss of Range of Motion; No Information; Pain; Scar Tissue; Swelling

  MAUDE report 9988283 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 0002648920-2020-00235.

  Patient problems: Loss of Range of Motion; Scar Tissue; Swelling

  MAUDE report 9988279 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, 6 MONTHS POST OPERATIVELY, A TENDON STARTED CATCHING ON HER IMPLANTS AND CAUSED SWELLING. PATIENT UNDERWENT ADDITIONAL PHYSICAL THERAPY AND THE KNEE LOCKED AT A 90 DEGREE ANGLE. PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA WHERE THE SURGEON ALSO CUT OUT SCAR TISSUE.

  Patient problems: Loss of Range of Motion; Scar Tissue; Swelling

  MAUDE report 9988264 ↗
• InjuryMar 17, 2020Adverse 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: Adhesion(s); Loss of Range of Motion

  MAUDE report 9842113 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, BLOATING, NAUSEA, SHORTNESS OF BREATH, AND VOMITING POST-OPERATIVELY DAY TWO AND MORNING OF DAY THREE. SUBSEQUENTLY, THE PATIENT EXPIRED ON POST-OPERATIVE DAY THREE DUE TO PROCEDURAL RELATED COMPLICATIONS INCLUDING DEEP VEIN THROMBOSIS (DVT) AND POSSIBLE PULMONARY EMBOLISM (PE). HOWEVER, THIS WAS UNABLE TO BE TESTED DUE TO THE PATIENT CONDITION. IT WAS ALSO NOTED THAT THERE WERE OCCLUSIVE AND NON-OCCLUSIVE THROMBUS LOCATED IN THE FEMORAL VEIN AS WELL AS NON-OCCLUSIVE THROMBUS LOCATED IN OTHER AREAS.

  Patient problems: Abdominal Pain; Cardiac Arrest; Death; Nausea; Pulmonary Embolism; Thrombosis; Thrombosis/Thrombus; Vomiting

  MAUDE report 8523535 ↗

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-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-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-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-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-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-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.