PERSONA® 42-5020-062-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024229914), received between Aug 17, 2022 and Aug 4, 2026 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a revision approximately 2 years and 8 months post-implantation due to flexion instability. It was reported that no further information is available.

  Patient problems: Joint Laxity

  MAUDE report 50133130 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  A MANUSCRIPT WAS OBTAINED ON (B)(6) 2026 THAT REPORTED A RANDOMIZED CONTROLLED TRIAL STUDY FROM THE NETHERLANDS CONDUCTED FROM (B)(6) 2022 AND (B)(6) 2024 AT (B)(6). THE PURPOSE OF THE STUDY WAS TO COMPARE ROBOTIC-ASSISTED INVERSE KINEMATIC ALIGNMENT TOTAL KNEE ARTHROPLASTY WITH MECHANICALLY ALIGNED TOTAL KNEE ARTHROPLASTY. A TOTAL OF 150 PATIENTS WERE INCLUDED AND UNDERWENT RANDOMIZATION; 73 PATIENTS WERE ASSIGNED TO THE ROSA ROBOTIC-ASSISTED TKA GROUP AND 77 PATIENTS TO THE CONVENTIONAL MA TKA GROUP. IN THE ROBOTIC-ASSISTED TKA GROUP, 7 PATIENTS WERE CONVERTED TO CONVENTIONAL TKA. A STANDARD MEDIAL PARAPATELLAR APPROACH WAS USED IN ALL PATIENTS; PATELLAR RESURFACING WAS DONE ONLY IN SELECTED CASES AND A FULLY CEMENTED, CRUCIATE RETAINING KNEE PROSTHESIS WAS IMPLANTED. ZIMMER BIOMET PERSONA WAS USED IN ALL CASES EXCEPT VANGUARD IN 2 CASES. THE STUDY POPULATION HAD A MEAN AGE OF 69.7 YEARS AT TIME OF SURGERY; (51 MALES / 77 FEMALES). FOLLOW-UP CONSISTED OF FUNCTIONAL AND SATISFACTION SCORING WITHIN 12 MONTHS WITH A MINIMUM FOLLOW UP OF 12 MONTHS. THE ARTICLE REPORTED ONE (1) PATIENT IN THE CONVENTIONAL GROUP EXPERIENCED POSTOPERATIVE PAIN ON AN UNKNOWN TIMEFRAME BEFORE THE TWELVE (

  Patient problems: Pain

  MAUDE report 25166947 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 23810342 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT REPORTED DIZZINESS, NAUSEA, FATIGUE, SHORTNESS OF BREATH, AND HYPOTENSION ABOUT THREE WEEKS POST TKA. THE PATIENT AND WAS TRANSFERRED TO THE EMERGENCY ROOM VIA EMS. A CT SCAN CONFIRMED A NONOCCLUSIVE SUB-SEGMENTAL PULMONARY EMBOLISM WITH LEFT UPPER LOBE AND WAS HOSPITALIZED FOR TWO DAYS FOR ANTICOAGULATION THERAPY. THE PATIENT WAS DISCHARGED HOME TWO DAYS LATER, PRESCRIBED ON APIXABAN FOR THREE MONTHS. AT THE THREE MONTH FOLLOW-UP, THE PATIENT WAS PROGRESSING WELL AND REMAINED SATISFIED WITH ALL IMPLANTS IN PLACE.

  Patient problems: Dizziness; Dyspnea; Fatigue; Low Blood Pressure/ Hypotension; Nausea; Pulmonary Embolism

  MAUDE report 19911740 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA STUDY THAT THE PATIENT DEVELOPED A PULMONARY EMBOLISM REQUIRING HOSPITALIZATION APPROXIMATELY FORTY (40) DAYS POST IMPLANTATION. NO FURTHER INTERVENTIONS HAVE BEEN REPORTED.

  Patient problems: Pulmonary Embolism

  MAUDE report 15244511 ↗

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-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-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-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-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
• 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-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.