PERSONA® 42-5020-064-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024229938), received between May 19, 2020 and May 13, 2026 — classified as 10 injuries, 1 malfunction.

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, 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS IN A JOURNAL ARTICLE THAT PATIENT REQUIRED WOUND EXCISION APPROXIMATELY 4 MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Impaired Healing

  MAUDE report 25162513 ↗
• InjuryDec 30, 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: Aseptic loosening

  MAUDE report 23924326 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING WEAKNESS, IMBALANCE, SWELLING, AND ACHING IN THE KNEE POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 22005370 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL BILATERAL KNEE ARTHROPLASTY. THE PATIENT REPORTS CHRONIC ISSUES WITH BOTH KNEES INCLUDING PAN AND SWELLING. THE PATIENT HAD AN MRI WITH FINDINGS OF BONE NECROSIS, QUADRICEPS AND PATELLA TENDINOSIS, PATELLAR TENDON PERFORATION, AND MODERATE EFFUSION. THE DEVICES REMAIN IMPLANTED AT THIS TIME.

  Patient problems: Inflammation; Muscle/Tendon Damage; Necrosis; Pain

  MAUDE report 21245604 ↗
• 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 KNEE ARTHROPLASTY. APPROXIMATELY 7 DAYS POST IMPLANTATION, THE PATIENT PRESENTED TO THEIR PRIMARY CARE PROVIDER AND WAS DIAGNOSED WITH DEEP VEIN THROMBOSIS. MEDICATION WAS GIVEN AS TREATMENT AND THIS WAS RESOLVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21055672 ↗
• InjuryNov 2, 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 PAIN, STIFFNESS, POPPING SENSATIONS, LIGAMENT LAXITY, INSTABILITY AND LIMITED ABILITY TO PERFORM DAILY ACTIVITIES APPROXIMATELY FIFTEEN (15) MONTHS POST-OPERATIVELY. THE ARTICULAR SURFACE AND FEMORAL COMPONENT WERE REVISED AND REPLACED AND A TIBIAL STEM ADDED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 WITH AT HOME THERAPY. REVISION OPERATIVE NOTES NOTED THE PATIENT'S PAIN BEGAN APPROXIMATELY SIX (6) MONTHS PRIOR, LIMITING DAILY ACTIVITY, AND THE PATIENT WAS ALSO EXPERIENCING INSTABILITY. DURING THE PROCEDURE, SEVERE VARUS-VALGUS LAXITY AND HYPEREXTENSION WERE NOTED. THE FEMORAL COMPONENT WAS IN GOOD ALIGNMENT AND REMOVED WITHOUT DIFFICULTY. SCLEROTIC AND NON-VIABLE BONE REQUIRED REMOVAL FROM THE FEMUR PRIOR TO PLACING THE NEW FEMORAL COMPONENT. A SEQUENTIALLY LARGER ARTICULAR SURFACE WAS USED TO ACHIEVE STABILITY AND THE TIBIAL BASEPLATE WAS PUNCHED TO ACCOMMODATE THE TIBIAL STEM. NO INTRAOPERATIVE COMPLICATIONS WERE IDENTIFIED.

  Patient problems: Ambulation or Postural Difficulties; Hyperextension; Joint Laxity; Necrosis; Pain

  MAUDE report 18061914 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AND LIMITED RANGE OF MOTION AND UNDERWENT A SYNOVECTOMY IN AN UNKNOWN TIME FRAME POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 17900485 ↗
• InjuryNov 29, 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; Thrombosis/Thrombus

  MAUDE report 12883861 ↗
• InjuryNov 9, 2021Adverse 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 PATELLA AND MEDIAL LIGAMENT INSTABILITY APPROXIMATELY NINETEEN (19) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 12778647 ↗
• MalfunctionNov 17, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10856364 ↗
• InjuryMay 19, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Muscular Rigidity; Patient Problem/Medical Problem

  MAUDE report 10069847 ↗

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-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-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-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-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-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

…and 24 more.