PERSONA™ 42-5400-000-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024247628), received between Sep 2, 2020 and Apr 15, 2025 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN, DIFFICULTY WALKING, LOOSENING OF IMPLANT, AND KNEE INSTABILITY POST IMPLANTATION. A BONE SCINTIGRAPHY TO VERIFY THE STATE OF THE PROSTHESIS AND IT WAS NOTED THE PROSTHESIS HAS FAILED. IT WAS NOTED IN REPORT THAT LOWER PART OF THE PROSTHESIS HAD FAILED. IT IS UNKNOWN WHICH COMPONENT IS LOOSEN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 21840595 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 2.5 MONTHS IMPLANTATION, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 16308609 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND DECREASED ACTIVITY POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 14944857 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY ABOUT 2 WEEKS POST PROCEDURE A MILD SUPERFICIAL SKIN INFECTION WAS NOTED AND TREATED WITH MEDICAL INTERVENTION THAT RESOLVED APPROXIMATELY ONE MONTH POST INTERVENTION.

  Patient problems: Skin Infection

  MAUDE report 13206332 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT DEVELOPED ILIOTIBIAL BAND TENDINITIS FOR WHICH PHYSICAL THERAPY WAS PRESCRIBED POST IMPLANTATION. UPON FOLLOW UP, THE PATIENT REPORTED NO IMPROVEMENT AND STILL EXPERIENCES INCREASED PAIN, SWELLING, AND STIFFNESS. ON EXAM, SHE HAS FULL RANGE OF MOTION, NO COMPLICATIONS ON IMAGING, AND NO SIGN OF INFECTION. FURTHER LAB WORKUP HAS BEEN ORDERED, BUT RESULTS HAVE NOT BEEN PROVIDED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

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

  MAUDE report 12778713 ↗
• InjuryOct 11, 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: Ambulation or Postural Difficulties; Hematoma; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 12605552 ↗
• InjuryOct 7, 2021Naturally Worn; Naturally Worn

  NO FURTHER EVENT INFORMATION AVAILABLE AT TIME OF THIS REPORT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12589613 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CLINICAL STUDY PATIENT UNDERWENT PRIMARY RIGHT KNEE. SUBSEQUENTLY PATIENT DEVELOPED AN EFFUSION OF RIGHT KNEE, AND ASPIRATION AND ULTRASOUND PERFORMED ABOUT 2 YEARS POST PROCEDURE AND 30CC OF FLUID REMOVED. IT IS NOTED THAT THE REPORTED EVENT RESOLVED WITHOUT FURTHER INCIDENT, AND PATIENT HAS COMPLETED CLINICAL STUDY AND REMAINS IMPLANTED.

  Patient problems: Swelling/ Edema

  MAUDE report 12354238 ↗
• InjuryAug 3, 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

  MAUDE report 12267791 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

  Patient problems: Swelling/ Edema

  MAUDE report 12192540 ↗
• InjuryMar 23, 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: Unspecified Infection

  MAUDE report 11556016 ↗
• InjuryOct 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TWO DAYS POST-INITIAL LEFT TKA DUE TO A FALL AND WOUND DEHISCENCE. SUBLUXATION OF THE PATELLA WAS NOTED ON X-RAY. ADDITIONALLY, DISRUPTION OF THE MEDIAL COLLATERAL LIGAMENT ATTACHMENT ON THE TIBIA OCCURRED. IT IS UNKNOWN WHAT CAUSED PATIENT TO FALL.

  Patient problems: Hematoma; Joint Dislocation; Pain

  MAUDE report 10705131 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DEEP VEIN THROMBOSIS APPROXIMATELY ONE WEEK AFTER RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS PRESCRIBED AN ANTICOAGULANT AND REMAINED ON IT FOR APPROXIMATELY 3 MONTHS WITH NO FURTHER MENTION OF DEEP VEIN THROMBOSIS.

  Patient problems: Embolism; Pain; Swelling

  MAUDE report 10482363 ↗

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-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-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-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-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-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-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.