PERSONA® 42-5006-068-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024229273), received between Nov 14, 2019 and Oct 11, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 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: Adhesion(s); Ambulation or Postural Difficulties; Joint Contracture; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17917218 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A LEFT TOTAL KNEE. SUBSEQUENTLY, ONE MONTH POST PROCEDURE, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO LIMITED RANGE OF MOTION. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 16859801 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS STIFFNESS, SWELLING, DISCOMFORT AND RECURRENT EFFUSIONS APPROXIMATELY FIVE YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Joint effusion; Swelling/ Edema

  MAUDE report 16763127 ↗
• InjuryNov 17, 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: Wound Dehiscence

  MAUDE report 12830600 ↗
• MalfunctionNov 17, 2021Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830580 ↗
• InjuryApr 1, 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

  INITIAL LEFT TOTAL KNEE ARTHROPLASTY PERFORMED. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH A DVT IN THE LEFT LOWER EXTREMITY ONE WEEK POST PROCEDURE, AND RESOLVED ONE WEEK LATER. AT THE 1 MONTH FOLLOW UP, THE PATIENT DEMONSTRATED INSUFFICIENT FLEXION AND REPORTED DISSATISFACTION WITH AN INABILITY TO PERFORM USUAL ACTIVITIES. THE PATIENT STARTED PHYSICAL THERAPY FOR TREATMENT.

  Patient problems: Loss of Range of Motion; Thrombosis/Thrombus

  MAUDE report 11602416 ↗
• MalfunctionNov 14, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9321170 ↗

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-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-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-2580-2014 · Aug 7, 2014 · Terminated
  PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3
• 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

…and 24 more.