PERSONA™ 42-5099-094-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 406 adverse event reports that list this exact device (DI 00889024232891), received between Dec 19, 2019 and Sep 28, 2026 — classified as 1 injury, 405 malfunctions.

The most frequently reported specific device problem is “Fracture” (404 reports).

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 25 most recent of 406 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Fracture

  It was reported that the femoral impactor pad broke. The breakage was discovered after the surgery. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916350 ↗
• MalfunctionSep 28, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916333 ↗
• MalfunctionSep 25, 2026Fracture

  It was reported that a crack and hole were identified in an impactor pad. The issue was discovered by the sterilization department. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900021 ↗
• MalfunctionSep 24, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884340 ↗
• MalfunctionSep 22, 2026Fracture

  It was reported that the femoral impactor broke during surgery. The surgical technique was utilized. There was no surgical delay. No foreign bodies were retained. Attempts have been made and all available information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858103 ↗
• MalfunctionSep 18, 2026Fracture

  It was reported the femoral impactor pad cracked and broke. There was no consequences or impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50816956 ↗
• MalfunctionAug 12, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226753 ↗
• MalfunctionAug 12, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226240 ↗
• MalfunctionAug 6, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155371 ↗
• MalfunctionAug 3, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114438 ↗
• MalfunctionJul 29, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071821 ↗
• MalfunctionJul 28, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059737 ↗
• MalfunctionJun 29, 2026Fracture

  IT WAS REPORTED THAT AN IMPACTOR PAD BROKE DURING FEMORAL TRIALING. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651939 ↗
• MalfunctionJun 23, 2026Fracture

  IT WAS REPORTED THAT A FEMORAL IMPACTOR PAD BROKE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25594109 ↗
• MalfunctionJun 23, 2026Fracture

  IT WAS REPORTED THAT WHILE IMPACTING THE FEMUR A PIECE OF THE IMPACTOR HEAD FRACTURED. THE PIECE THAT BROKE OFF DIDN¿T AFFECT THE ABILITY TO IMPACT THE FEMORAL IMPLANT. THE SURGICAL TECHNIQUE WAS UTILIZED. NO PIECES FELL INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593127 ↗
• MalfunctionJun 22, 2026Fracture

  IT WAS REPORTED THAT AN IMPACTOR PAD FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25577201 ↗
• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT AN IMPACTOR PAD FRACTURED WHILE IMPACTING THE FINAL FEMORAL COMPONENT. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY OR FOREIGN BODIES RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742642 ↗
• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT A CORNER OF THE CRUCIATE-RETAINING FEMORAL IMPACTOR PAD BROKE OFF DURING IMPACTION OF THE FINAL IMPLANT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741528 ↗
• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT A FEMUR IMPACTOR BROKE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741469 ↗
• MalfunctionMar 23, 2026Fracture

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR PAD WAS RETURNED TO THE MANUFACTURER FRACTURED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660962 ↗
• MalfunctionMar 20, 2026Fracture

  IT WAS REPORTED THAT WHILE ADJUSTING THE FEMORAL PROSTHESIS, THE IMPACTOR FRACTURED INTO 2 PIECES. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM AND NO FOREIGN BODIES WERE RETAINED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE CUSTOMER SUSPECTS THIS IS DUE TO MATERIAL FATIGUE. THE CUSTOMER SUSPECTS THIS IS DUE TO MATERIAL FATIGUE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649462 ↗
• MalfunctionMar 3, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495250 ↗
• MalfunctionFeb 26, 2026Fracture

  IT WAS FURTHER REPORTED THAT THERE WAS A 10 MINUTE SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. NO FOREIGN BODIES WERE RETAINED. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457550 ↗
• MalfunctionFeb 17, 2026Fracture

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE PAD OF THE IMPACTOR INSTRUMENT FRACTURED. 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 24367253 ↗
• MalfunctionFeb 4, 2026Fracture

  IT WAS REPORTED THAT THE IMPACTOR PAD BROKE WHILE THE SURGEON WAS IMPLANTING THE FEMORAL COMPONENT. THE SURGICAL TECHNIQUE WAS UTILIZED, THERE WAS NO SURGICAL DELAY, THERE WERE NO FOREIGN BODIES RETAINED ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257113 ↗

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-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-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-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-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-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-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

…and 24 more.