PERSONA™ 42-5400-000-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024247659), received between Mar 13, 2020 and Sep 19, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 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 REVISION APPROXIMATELY 1.5 YEARS POST IMPLANTATION DUE TO MID-FLEXION INSTABILITY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 17772581 ↗
• InjuryJul 20, 2021Unstable; Unstable

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

  Patient problems: Pain

  MAUDE report 12198249 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY FOR LYSIS OF ADHESIONS APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUD TO PAIN, LIMITED MOBILITY, STIFFNESS, AND ADHESIONS. THE PATIENT CONTINUES TO REPORT PAIN AND STIFFNESS. THE SITE REPORTS THE OUTCOME HAS SINCE RESOLVED.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Pain

  MAUDE report 11285799 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS ADMITTED TO THE HOSPITAL APPROXIMATELY TWO WEEKS AFTER INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, DUE TO PAIN AND SWELLING, AS WELL AS BLISTERS AROUND AN ABRASION ON THE FOOT. SUBSEQUENTLY, THE PATIENT WAS DISCHARGED FOUR DAYS LATER WITH A DIAGNOSIS OF CELLULITIS AND SUPERFICIAL INFECTION AROUND THE FOOT, AS THE KNEE INCISION HEALED WITHOUT ISSUE. AT THE THREE MONTH FOLLOW-UP FROM IMPLANTATION, THE SWELLING WAS NOTED AS RESOLVED, AND IMPROVING RANGE OF MOTION AND PAIN LEVELS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Cellulitis; Loss of Range of Motion; Pain; Swelling; Swelling/ Edema; Unspecified Infection

  MAUDE report 11154533 ↗
• InjuryOct 23, 2020Noise, Audible; Noise, Audible

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

  Patient problems: Nerve Damage; Pain; Swelling; Synovitis

  MAUDE report 10726886 ↗
• InjurySep 9, 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: Embolism

  MAUDE report 10510999 ↗
• InjurySep 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Damage to Ligament(s); Joint Dislocation; Pain; Patient Problem/Medical Problem; Scar Tissue; Swelling; Tissue Damage

  MAUDE report 10478427 ↗
• InjuryAug 3, 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: Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Scar Tissue

  MAUDE report 10356062 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED BILATERAL TOTAL KNEE ARTHROPLASTIES PERFORMED APPROXIMATELY TWO YEARS AGO. AT THE ONE YEAR POSTOP VISIT, THE PATIENT REPORTED MODERATE PAIN, STIFFNESS WITH SITTING, AND SOME INSTABILITY IN THE RIGHT KNEE. NO INTERVENTION OR TREATMENT HAS BEEN GIVEN, AND THE PATIENT REMAINS SATISFIED.

  Patient problems: Limited Mobility Of The Implanted Joint; Muscular Rigidity; Pain

  MAUDE report 10029366 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STUDY PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY AND WAS DIAGNOSED WITH A RIGHT LOWER EXTREMITY DVT LESS THAN 3 MONTHS POST-OP. MEDICAL INTERVENTION OCCURRED, AND THE OUTCOME HAS BEEN NOTED AS RESOLVED.

  Patient problems: Embolism

  MAUDE report 9829643 ↗

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-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-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-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-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-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-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.