PERSONA® 42-5006-068-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024229280), received between Apr 3, 2020 and Jan 26, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Packaging Problem

  IT WAS REPORTED THE IMPLANT PACKAGING APPEARED TO BE MELTED PRIOR TO USE. THE DEVICE WAS NOT USED AND A SECONDARY IMPLANT WAS RETRIEVED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177759 ↗
• MalfunctionJan 12, 2026Packaging Problem

  IT WAS REPORTED THAT DURING SURGERY, THE INNER PACKAGING APPEARED TO BE DEFORMED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039881 ↗
• MalfunctionSep 5, 2025Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979508 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SWELLING AND OTHER UNSPECIFIED POST-OPERATIVE COMPLICATIONS APPROXIMATELY FOUR (4) YEARS FOLLOWING RIGHT KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Swelling/ Edema

  MAUDE report 21731072 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT BEGAN TO EXPERIENCE PAIN, WARMTH, EFFUSION, AND DECREASED RANGE OF MOTION ABOUT THREE YEARS TWO MONTHS POST IMPLANTATION AND AN ASPIRATION OF THE SYNOVIAL FLUID WAS COMPLETED. THREE DAYS LATER THE PATIENT UNDERWENT AN I&D, WITH POLY EXCHANGE, FOR A PERIPROSTHETIC INFECTION WITHOUT COMPLICATION. AFTER COMPLETING IV AND ORAL ANTIBIOTICS, THE PATIENT BEGAN TO EXPERIENCE PAIN, SWELLING, LIMITED RANGE OF MOTION, AND DIFFICULTY AMBULATING. EIGHT MONTHS AFTER THE I&D, AN ASPIRATION WAS COMPLETED AND THE CULTURE RESULTS INDICATED AN ONGOING INFECTION RELATED TO STAPH EPIDERMITIS. SUBSEQUENTLY, THE PATIENT UNDERWENT THE FIRST STAGE OF A TWO STAGE REVISION WHERE ALL IMPLANTS WERE REMOVED AND A TEMPORARY SPACER WAS IMPLANTED. APPROXIMATELY TWO MONTHS LATER, THE PATIENT UNDERWENT THE SECOND STAGE REVISION WHERE MODERATE OSTEOLYSIS WAS NOTED AROUND THE TIBIAL AND FEMORAL COMPONENTS THAT WAS CONSISTENT WITH THE PREVIOUS INFECTION/EXPLANTATION AND A REVISION KNEE SYSTEM WAS IMPLANTED WITHOUT COMPLICATION.

  Patient problems: Ambulation or Postural Difficulties; Bacterial Infection; Joint effusion; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19668835 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY PERFORMED. SUBSEQUENTLY, APPROXIMATELY 10 MONTHS POST PROCEDURE, THE PATIENT UNDERWENT AN ARTHROSCOPIC LYSIS OF ADHESIONS WITH MANIPULATION DUE TO PAIN AND STIFFNESS. AT FOLLOW UP, THE PATIENT WAS SATISFIED WITH HIS PROGRESS AND COMPLIANT WITH PHYSICAL THERAPY.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 11656892 ↗
• InjuryApr 3, 2020Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

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

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; No Code Available; Pain; Swelling

  MAUDE report 9921771 ↗

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-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-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-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
• 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

…and 24 more.