PERSONA® 42-5006-060-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024229204), received between Dec 16, 2020 and Aug 22, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO MONTHS POST-RESOLUTION OF PREVIOUS INCIDENT PATIENT BEGAN TO AGAIN EXPERIENCE DISCOMFORT WITH THE IMPLANTED PROSTHESIS. STEROID MEDICATION WAS PRESCRIBED AND NO ADDITIONAL INTERVENTION WAS REQUIRED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Loss of Range of Motion; Pain

  MAUDE report 22871995 ↗
• InjuryApr 17, 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: Inflammation; Swelling/ Edema

  MAUDE report 19124145 ↗
• InjuryMar 26, 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: Alteration in Body Temperature; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 18979195 ↗
• InjuryOct 31, 2023Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT COMPLAINED OF PAIN, SWELLING, LIMITED EXTENSION, SEVERE LIMP, AND CHRONIC QUADRICEP WEAKNESS. THE THE SURGEON SUSPECTED A QUADRICEP TENDON TEAR. APPROXIMATELY ONE YEAR, SIX MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION WHERE SIGNIFICANT SCAR TISSUE WAS ENCOUNTERED DUE TO PATELLA BAJA BUT ALL PATELLA AND QUADRICEP TENDONS WERE FOUND INTACT. THE FEMORAL, TIBIA, AND POLY WERE REVISED WITH COMPETITOR PRODUCTS. THE PATELLA WAS NOT REVISED. THE PATIENT IS ALLEGING HER COMPONENTS WERE TOO LARGE.

  Patient problems: Ambulation or Postural Difficulties; Joint effusion; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 18040564 ↗
• InjuryOct 16, 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: Unspecified Infection

  MAUDE report 17938419 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA TO ADDRESS PAIN, SWELLING AND STIFFNESS SIX (6) WEEKS FOLLOWING RIGHT KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS AND THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION. THE PATIENT'S POST-OPERATIVE RANGE OF MOTION WAS ZERO (0) TO ONE HUNDRED THIRTY (130) DEGREES. OUTPATIENT THERAPY WAS INSTRUCTED FOR RANGE OF MOTION AND PAIN MANAGEMENT. MANIPULATION OPERATIVE NOTES NOTED THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA WITH A CORTICOSTEROID INJECTION TO ADDRESS RIGHT KNEE STIFFNESS. UTILIZING GENTLE PRESSURE, KNEE FLEXION WAS INCREASED WITH AUDIBLE LYSIS OF ADHESIONS. THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 14652845 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY WITHOUT COMPLICATIONS. SUBSEQUENTLY, THE PATIENT HAS REPORTED ONGOING PAIN, SWELLING, AND POPPING IN THE KNEE FOR THE PAST FOUR YEARS AND TWO MONTHS SINCE IMPLANTATION. ADDITIONALLY, THE PATIENT IS HAVING RANGE OF MOTION ISSUES WITH ONE KNEE AND CANNOT BEND OR KNEEL. THE PATIENT HAS HAD BILATERAL KNEE REPLACEMENTS AND IT IS UNKNOWN WHICH KNEE IS HAVING RANGE OF MOTION COMPLICATIONS. NO MEDICAL INTERVENTION HAS BEEN REPORTED AT THE TIME OF THIS REPORT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 14437665 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS, WOUND DEHISCENCE AND LIMITED FLEXION IN KNEE TWO MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 14237872 ↗
• InjuryDec 16, 2020Adverse 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: No Code Available; Pain

  MAUDE report 11021665 ↗

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-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.