PERSONA® 42-5400-000-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024643703), received between Apr 12, 2022 and Apr 23, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 6 MONTHS BEFORE, THE PATIENT REPORTED EXPERIENCING A POPPING SENSATION. ON EVALUATION, THE PATIENT DEMONSTRATED GOOD STABILITY, BALANCE, AND APPROPRIATE PATELLAR TRACKING. THE PATIENT WAS DIAGNOSED WITH PATELLAR TENDINITIS, PES ANSERINE BURSITIS, AND ILIOTIBIAL BAND INSERTIONAL TENDERNESS. TREATMENT INCLUDED A LEFT BURSA INJECTION AND A LEFT ILIOTIBIAL BAND INJECTION. THE PATIENT WAS ALSO INSTRUCTED TO APPLY A TOPICAL ANTI-INFLAMMATORY CREAM AND WAS PROVIDED WITH A COMPRESSION STOCKING. THERE WERE NO CONCERNS OR ALLEGATIONS REGARDING THE IMPLANTED COMPONENTS, WHICH REMAIN IN PLACE. THE EVENT HAS BEEN REPORTED AS RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Discomfort; Tendinopathy

  MAUDE report 24965642 ↗
• InjuryOct 27, 2025Adverse 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: Muscle/Tendon Damage

  MAUDE report 23392643 ↗
• InjurySep 15, 2025Biocompatibility; Biocompatibility

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

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

  MAUDE report 23057558 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA). APPROXIMATELY ONE YEAR LATER, THE PATIENT REPORTED MILD PAIN AND STIFFNESS AND IS CURRENTLY RECEIVING PHYSICAL THERAPY. ALL COMPONENTS REMAIN IMPLANTED, AND THE EVENT IS RESOLVING.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 22972805 ↗
• 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 22903406 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT REPORTED MODERATE PAIN TO THE KNEE WITH EXTREME PAIN STANDING UPRIGHT AND BENDING TO THE FLOOR DURING THE TWO YEAR FOLLOW UP. THE PATIENT HAS IMPROVED AS THE STUDY CONTINUED, ALL RADIOGRAPHIC IMAGING DISPLAYS NO SIGNIFICANT FINDINGS, AND ALL PRODUCTS REMAIN IMPLANTED.

  Patient problems: Pain

  MAUDE report 22077593 ↗
• 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 22005369 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS EXPERIENCING PAIN, STIFFNESS, AND SWELLING TWO YEARS POST-OP POST IMPLANTATION FOR WHICH PHYSICAL THERAPY HAS BEEN PRESCRIBED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

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

  MAUDE report 21882630 ↗
• InjuryMar 14, 2025Adverse 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 21605935 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS ACCOMPANIED BY PAIN AND LOWER LEG SWELLING APPROXIMATELY ONE (1) WEEK FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT STAYED OVERNIGHT AT THE HOSPITAL AND TREATED WITH ELIQUIS WHILE INPATIENT AND WAS PRESCRIBED XARELTO WHEN RELEASED. THE PATIENT APPEARED TO BE IMPROVING WHEN SEEN TWO (2) WEEKS LATER. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s); Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 21055551 ↗
• 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 19911696 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTS PAIN AND SWELLING AND THAT THEY CANNOT BEND THEIR KNEE WELL. THE PATIENT ALSO HAS A BAKER'S CYST ON THE BACK OF THE KNEE THAT STARTED ABOUT 4 WEEKS POST-OP AND HAS BEEN PRESCRIBED ANTIBIOTICS ON AND OFF SINCE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 17152200 ↗
• InjuryApr 11, 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 ARTHROSCOPY APPROXIMATELY SEVEN (7) MONTHS POST-OPERATIVELY TO ADDRESS PATELLAR CLUNK AND A CATCHING FEELING. DURING THE ARTHROSCOPY, SYNOVITIS AND FIBROUS TISSUE AT THE SUPERIOR POLE OF THE PATELLA WERE IDENTIFIED AND APPEARED TO BE ENGAGING WITH THE BOX OF THE FEMUR AND WAS SCARRED THROUGH THE MEDIAL GUTTER. A SYNOVECTOMY WAS PERFORMED, AND SCAR TISSUE WAS REMOVED WITHOUT COMPLICATION. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue; Synovitis

  MAUDE report 16714413 ↗
• InjuryMar 29, 2023Adverse 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: Insufficient Information

  MAUDE report 16635665 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD AN ARTHROSCOPY WITH LYSIS OF ADHESIONS APPROXIMATELY 10 MONTHS LATER DUE TO ARTHROFIBROSIS, STIFFNESS, PAIN, DIFFICULTY WALKING, AND ADLS. THE PATIENT'S ISSUES RESOLVED APPROXIMATELY 2 WEEKS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 15551392 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3.5 YEARS POST IMPLANTATION DUE TO PAIN, SWELLING, AND INSTABILITY. DURING THE SURGERY, IT WAS NOTED THAT THE PATELLAR COMPONENT HAD INCOMPLETE COVERAGE AND THERE WAS A SMALL AREA OF NECROSIS ON THE CENTER OF THE PATELLA. THE ARTICULAR SURFACE AND PATELLA WERE EXCHANGED AND THE SURGERY WAS COMPLETE WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Necrosis; Pain; Swelling/ Edema

  MAUDE report 14310404 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO DECREASED RANGE OF MOTION, ADHESIONS, AND SCAR TISSUE. THE ISSUE WAS RESOLVED.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 14086750 ↗

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-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-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-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-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-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-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.