PERSONA® 42-5006-064-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024229235), received between Oct 23, 2019 and Jun 1, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 3 YEARS AND 11 MONTHS POST-IMPLANTATION DUE TO PAIN AND LOOSENING. THE PRIMARY POSTERIOR-STABILIZED KNEE COMPONENTS WERE REVISED TO A REVISION KNEE SYSTEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 25346966 ↗
• InjuryDec 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY. SUBSEQUENTLY, A BONE SCAN WAS PERFORMED THAT INDICATED FEMORAL LOOSENING AND THE PATIENT WAS REVISED APPROXIMATELY 9 MONTHS POST-OP. THE FEMORAL COMPONENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening

  MAUDE report 23778734 ↗
• InjuryNov 13, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING SWELLING AND POSSIBLE ALLERGIC REACTION APPROXIMATELY TWO YEARS SEVEN MONTHS POST IMPLANTATION. THE PATIENT CALLED STATING HE NEEDS TO KNOW IF HIS IMPLANT CONTAINS NICKEL AS HE HAS BEEN FOUND TO BE ALLERGIC TO NICKEL AND WAS ADVISED THAT IMPLANT MATERIAL COMPOSITION COULD NOT BE PROVIDED WITHOUT SPECIFIC PRODUCT INFORMATION.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 23544401 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22903279 ↗
• InjuryOct 29, 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: Loss of Range of Motion

  MAUDE report 20560503 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 10 MONTHS POST IMPLANTATION DUE TO PAIN, SWELLING, AND INSTABILITY. DURING THE REVISION, SCAR TISSUE WAS DEBRIDED AND A MANIPULATION UNDER ANESTHESIA WAS PERFORMED, AND THE COMPONENTS WERE NOTED TO BE WELL FIXED. ALL IMPLANTS WERE REPLACED WITHOUT COMPLICATIONS.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20521544 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TEN (10) WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. THE ARTICULAR SURFACE, FEMORAL COMPONENT, AND PATELLAR IMPLANT WERE EXCHANGED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 20128648 ↗
• InjuryJun 25, 2024Migration; Migration

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

  Patient problems: Failure of Implant; Loss of Range of Motion; Scar Tissue

  MAUDE report 19607669 ↗
• InjuryJun 21, 2024Adverse 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. SUBSEQUENTLY, THE PATIENT UNDERWENT ARTHROSCOPY OF THE LEFT KNEE APPROXIMATELY 1 YEAR POST-OP FOR UNKNOWN REASONS WITH FINDINGS OF SYNOVITIS AND POSSIBLE ILIOTIBIAL BAND TIGHTNESS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Synovitis

  MAUDE report 19583043 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, OVER TWO (2) YEARS POST-IMPLANTATION, THE PATIENT IS EXPERIENCING PAIN, SWELLING, STIFFNESS, AND TROUBLE WALKING WITH THE LEFT KNEE. NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 17350475 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. LEGAL COUNSEL IS REPORTING PATIENT HAS FILED AN UNKNOWN ALLEGATION. PATIENT HAS NOT BEEN REVISED TO DATE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15950496 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT LEFT KNEE REVISION APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO PAIN. DURING THE REVISION, BONE LOSS WAS NOTED ON THE PATIENT'S FEMORAL AFTER REMOVAL OF THE IMPLANT.

  Patient problems: Pain

  MAUDE report 15538276 ↗
• InjuryAug 9, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT STARTED TO EXPERIENCE PAIN IN THE KNEE. THE PRODUCTS WERE ULTIMATELY REVISED FOUR YEARS AND FOUR MONTHS POST INITIAL IMPLANTATION. DURING THE SURGERY, THE ARTICULAR SURFACE WAS FOUND TO BE WORN, THE TIBIAL COMPONENT WAS FOUND TO HAVE LOOSENED AND MIGRATED, AND THE FEMORAL COMPONENT WAS LOOSENED. THE SURGEON THEORIZED THAT THE LOOSENING WAS CAUSED BY AN INFLAMMATORY REACTION TO ABRASION PARTICLES AND CEMENT TECHNIQUE ERROR. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15190759 ↗
• InjuryJan 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO MONTHS POST IMPLANTATION, THE PATIENT PRESENTED WITH SYMPTOMS INCLUDING PAIN, STIFFNESS, AND LIMITED RANGE OF MOTION. THE PATIENT THEN UNDERWENT A MANIPULATION UNDER ANESTHESIA WITHOUT COMPLICATION. AT THE INITIAL POST OPERATIVE VISIT, THE PATIENT EXHIBITED INCREASED RANGE OF MOTION AND SLOW RELEASE OF ADHESIONS.

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

  MAUDE report 13307618 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT'S FEMORAL DEVICE WAS REVISED ON (B)(6) 2020 DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 10698317 ↗
• InjurySep 16, 2020Loss 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

  UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: No Code Available

  MAUDE report 10542132 ↗
• MalfunctionOct 23, 2019Packaging Problem; Packaging Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 9225246 ↗

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-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-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-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

…and 24 more.