PERSONA® Natural Tibia® 42-5320-083-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024471122), received between Oct 10, 2019 and Sep 18, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

40 other recalls cover devices cleared under the same FDA submission (K113369, K122765, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 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: Joint Laxity

  MAUDE report 17763618 ↗
• InjuryJun 6, 2022Material Erosion; Unstable; Adverse Event Without Identified Device or Use Problem; Material Erosion; Unstable; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TKA WITH DR (B)(6) -STANDARD PRIMARY WITH CONE. SCREW BELOW IMPLANT THAT COULDN¿T BE REMOVED SO NO STEM USED. PATIENT HAD BECOME VERY UNSTABLE LATERALLY SO CAME FOR REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION. ONCE OPENED UP WE FOUND POLY HAD BE SMASHED ON THE POSTERIOR MEDIAL CORNER. IT WAS HYPOTHESISED THAT MAYBE THE TIBIAL TRAY WAS KICKED INTO TOO MUCH EXTERNAL ROTATION WHICH CAUSED THE FEMUR TO CONTACT MORE POSTERIOR AND THE PATIENT MAY HAVE SUBLUXED POSTEROMEDIALLY. THERE WAS METALOSSIS IN THE JOINT FROM THE FEMUR RUBBING ON THE TIBIAL COMPONENT AS SEEN IN THE ATTACHED PICTURE OF EXPLANTED TIBIA. CONE WAS REMOVED AS WE COULDN¿T FIX ROTATION. COMPETITOR PRODUCT PERIMETER CONE USED WITH PRIMARY BASEPLATE AND STUBBY STEM AND ROTATION WAS CHANGED TO IMPROVE CONTACT POINT.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 14604259 ↗
• InjuryOct 10, 2019Loss of or Failure to Bond; Unstable; Noise, Audible; Loss of or Failure to Bond; Unstable; Noise, Audible

  IT WAS REPORTED THE PATIENT BEGAN EXPERIENCING PAIN ALONG WITH CLICKING AND INSTABILITY APPROXIMATELY ONE YEAR POST TOTAL KNEE ARTHROPLASTY. A BONE SCAN AND X-RAY INDICATED THE TIBIAL PLATE WAS LOOSE. PATIENT HAS BEEN INDICATED FOR REVISION, HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE.

  Patient problems: Pain

  MAUDE report 9177045 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113369, K122765, K172524. One submission often covers many models, so check the product and lot details in each record.

• Z-1224-2018 · Dec 12, 2017 · Terminated
  PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumati
• 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-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-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-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-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

…and 25 more.