NA 5450-32-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 10603295174271), received between Nov 29, 2017 and Jun 24, 2025 — classified as 1 death, 144 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (68 reports).

1 other recall cover devices cleared under the same FDA submission (K033382, K033563, K053002, K061144, K081163); 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 150 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WITH RA WAS REVISED DUE TO LOOSENING COMPONENTS AT CEMENT TO BONE INTERFACE. NO ADVERSE CONSEQUENCES REPORTED. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22323755 ↗
• InjuryApr 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2023 PATIENT HAD UNDERWENT RIGHT KNEE WITH VELYS. ON (B)(6) 2025, PATIENT UNDERWENT A RIGHT TKA REVISION DUE TO PAIN, SWELLING, AND INSTABILITY. PATIENT WAS FOUND TO HAVE ASEPTIC FEMORAL AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS UNDERLYING FIBROUS TISSUE AND THE CEMENT WAS REMOVED AFTER THE TIBIAL COMPONENT AND FEMORAL COMPONENTS WERE REMOVED. THE PATELLA WAS NOTED TO HAVE BEEN REMOVED AS WELL, BUT THERE WAS NO MENTION IMPLANT LOOSENING RELATED TO THE PATELLA. COMPETITOR IMPLANTS WERE PLACED AT REVISION. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fibrosis; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21882001 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO KNEE INFECTION. COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21410273 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO KNEE INFECTION . COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21410244 ↗
• MalfunctionOct 3, 2024Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2024. FOUR UNITS OF ANTIBIOTIC BONE CEMENT DID NOT MIX CORRECTLY AND WERE WASTED. OTHER CEMENT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 20363664 ↗
• MalfunctionOct 3, 2024Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2024. FOUR UNITS OF ANTIBIOTIC BONE CEMENT DID NOT MIX CORRECTLY AND WERE WASTED. OTHER CEMENT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 20363577 ↗
• MalfunctionOct 3, 2024Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2024. FOUR UNITS OF ANTIBIOTIC BONE CEMENT DID NOT MIX CORRECTLY AND WERE WASTED. OTHER CEMENT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 20363402 ↗
• MalfunctionOct 3, 2024Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2024. FOUR UNITS OF ANTIBIOTIC BONE CEMENT DID NOT MIX CORRECTLY AND WERE WASTED. OTHER CEMENT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 20363335 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON STATED THAT PATIENT WAS INFECTED AND ELECTED TO CHANGE ALL COMPONENTS. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18340493 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON STATED THAT PATIENT WAS INFECTED AND ELECTED TO CHANGE ALL COMPONENTS. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023. DOR- DECEMBER 07, 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18339692 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 28-MAY-2021, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY INCLUDING PATELLA RESURFACING AND USE OF DEPUY SYNTHES BONE CEMENT. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. ON 23-JUL-2021, THE PATIENT WAS REVISED DUE TO SYMPTOMS OF PAIN, BURNING, AND INSTABILITY WITH XRAY SUGGESTION THAT THERE WAS LIKELY A POLY SPINOUT. INTRAOPERATIVE FINDINGS WERE THAT THE EXTENSOR MECHANISM WAS EXTREMELY POOR AT THE QUADRICEPS TENDON DUE TO THE PATIENT RECENTLY BEING OPERATED ON. THE POLY WAS CONFIRMED TO HAVE SPUN OUT. ALL COMPONENTS WERE REMOVED WITH EXCEPTION OF THE PATELLA AND AN SROM HINGED CONSTRUCT WAS PLACED. THE SROM HINGE WAS SELECTED AS THE PATIENT WOULD HAVE REQUIRED TOO LARGE OF A POLY INSERT TO CAUSE PATELLA BAJA. THERE WERE NO FURTHER COMPLICATIONS NOTED AFTER THE REVISION. DOI: (B)(6) 2021; DOR: JULY 23, 2021, RIGHT KNEE.

  Patient problems: Discomfort; Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18250181 ↗
• DeathNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR PE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2009. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: ADVERSE EVENT RESULTED IN DEATH.

  Patient problems: Pulmonary Embolism

  MAUDE report 18138918 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINS OF PAINFUL TKA WITH INSTABILITY NOTED ON EXAM. A THICKER INSERT TRIAL WAS ATTEMPTED WHICH ADDRESSED THE INSTABILITY, HOWEVER THE PATIENT HAD SIGNIFICANT PATELLA BAJA RENDERING THE KNEE TO BE UNACCEPTABLE IN THE SURGEONS OPINION. ALL COMPONENT WERE REMOVED, JOINT LINE WAS SHIFTED DISTALLY AND REVISION TOOK PLACE UNEVENTFULLY. NO PATIENT HARM OCCURRED. THE INDEX PROCEDURE WAS PERFORMED WITH TRUMATCH GUIDES ALL COMPONENTS WERE APPROPRIATELY SIZED , ALIGNED AND WERE WELL FIXED. NO POLY WEAR WAS NOTED. NO DELAY OCCURRED. DOI: (B)(6), 2020. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18046153 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINS OF PAINFUL TKA WITH INSTABILITY NOTED ON EXAM. A THICKER INSERT TRIAL WAS ATTEMPTED WHICH ADDRESSED THE INSTABILITY, HOWEVER, THE PATIENT HAD SIGNIFICANT PATELLA BAJA RENDERING THE KNEE TO BE UNACCEPTABLE IN THE SURGEONS OPINION. ALL COMPONENTS WERE REMOVED, JOINT LINE WAS SHIFTED DISTALLY AND REVISION TOOK PLACE UNEVENTFULLY. NO PATIENT HARM OCCURRED. THE INDEX PROCEDURE WAS PERFORMED WITH TRUMATCH GUIDES. ALL COMPONENTS WERE APPROPRIATELY SIZED, ALIGNED AND WERE WELL FIXED. NO POLY WEAR WAS NOTED. NO DELAY OCCURRED. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18031333 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINS OF PAINFUL TKA WITH INSTABILITY NOTED ON EXAM. A THICKER INSERT TRIAL WAS ATTEMPTED WHICH ADDRESSED THE INSTABILITY, HOWEVER, THE PATIENT HAD SIGNIFICANT PATELLA BAJA RENDERING THE KNEE TO BE UNACCEPTABLE IN THE SURGEONS OPINION. ALL COMPONENTS WERE REMOVED, JOINT LINE WAS SHIFTED DISTALLY AND REVISION TOOK PLACE UNEVENTFULLY. NO PATIENT HARM OCCURRED. THE INDEX PROCEDURE WAS PERFORMED WITH TRUMATCH GUIDES. ALL COMPONENTS WERE APPROPRIATELY SIZED, ALIGNED AND WERE WELL FIXED. NO POLY WEAR WAS NOTED. NO DELAY OCCURRED. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18031317 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINS OF PAINFUL TKA WITH INSTABILITY NOTED ON EXAM. A THICKER INSERT TRIAL WAS ATTEMPTED WHICH ADDRESSED THE INSTABILITY, HOWEVER, THE PATIENT HAD SIGNIFICANT PATELLA BAJA RENDERING THE KNEE TO BE UNACCEPTABLE IN THE SURGEONS OPINION. ALL COMPONENTS WERE REMOVED, JOINT LINE WAS SHIFTED DISTALLY AND REVISION TOOK PLACE UNEVENTFULLY. NO PATIENT HARM OCCURRED. THE INDEX PROCEDURE WAS PERFORMED WITH TRUMATCH GUIDES. ALL COMPONENTS WERE APPROPRIATELY SIZED, ALIGNED AND WERE WELL FIXED. NO POLY WEAR WAS NOTED. NO DELAY OCCURRED. DOI: (B)(6) 2020, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18031191 ↗
• InjuryAug 23, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS CONVERTED TO A REVERSE SHOULDER AS THE SURGEON STATED THAT HE BELIEVED THE PATIENT TORE HER RC DURING THERAPY AND MADE THE JOINT UNSTABLE AND WAS ROCKING THE GLENOID IMPLANT AND IT LOOSENED AND BECAME DISLODGED. LOOSENING OF THE GLENOID COMPONENT AT THE BONE TO CEMENT INTERFACE WAS REPORTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17606919 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE, EXPLANTED AND ANTIBIOTICS SPACER IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16572607 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE, EXPLANTED AND ANTIBIOTICS SPACER IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16572601 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE, EXPLANTED AND ANTIBIOTICS SPACER IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16572599 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE, EXPLANTED AND ANTIBIOTICS SPACER IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16572596 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN SHOULDER REGION AFTER SHOULDER REPLACEMENT; CHRONIC PAIN EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2020. (RIGHT SHOULDER). TREATMENT: INITIAL WORK UP FOR INFECTION WITH BLOOD WORK.

  Patient problems: Loss of Range of Motion; Nerve Damage; Numbness; Pain; Paresthesia; Unspecified Infection

  MAUDE report 15952031 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CONTINUED PAIN AND LIMITED ROM. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: ASPIRATION/DRAINAGE (ASPIRATE SENT FOR SYNVASURE AND CULTURE) AND ORAL MEDICATION.

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

  MAUDE report 15851997 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15198518 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15193405 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033382, K033563, K053002, K061144, K081163. One submission often covers many models, so check the product and lot details in each record.

• Z-1246-2015 · Feb 11, 2015 · Terminated
  SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis