BIOMET® BONE CEMENT R 110035368Recalls & reported problems
Biomet · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet bone cement R, used in joint replacement surgery, has 94 reports, 83 of them injuries, and 3 deaths. Common reports describe pain, implants loosening after knee replacement, bone loss, and repeat surgery. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 92
- Deaths reported
- 3
- Injuries reported
- 82
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00887868214578), received between Jan 2, 2020 and Sep 10, 2026 — classified as 3 deaths, 82 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (38 reports).
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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth38
- Adverse Event Without Identified Device or Use Problem33
- Patient Device Interaction Problem13
- Improper Chemical Reaction4
- Unsealed Device Packaging3
- Unstable2
- Activation, Positioning or Separation Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Pain51
- Failure of Implant26
- Ambulation or Postural Difficulties13
- Swelling/ Edema12
- Aseptic loosening11
- Loss of Range of Motion10
- Unspecified Infection9
- Inflammation6
Recent adverse event reports
The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that the patient underwent an initial right knee arthroplasty. Subsequently, approximately seventeen months post-implantation, the patient underwent revision surgery due to loosening of the femoral component.Due diligence is in progress for this complaint; no further information has been received at the time of this report.
Patient problems: Aseptic loosening
MAUDE report 50715458 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Loss of Range of Motion; Pain
MAUDE report 50519229 ↗InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT DEVELOPED PAIN AND SUFFERING AND MECHANICAL SYMPTOMS IN THE RIGHT KNEE FOLLOWING A TOTAL KNEE ARTHROPLASTY. NO INTERVENTION HAS BEEN REPORTED TO DATE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 25270644 ↗InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT DEVELOPED PAIN AND SUFFERING AND MECHANICAL SYMPTOMS IN THE RIGHT KNEE FOLLOWING A TOTAL KNEE ARTHROPLASTY. NO INTERVENTION HAS BEEN REPORTED TO DATE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 25270578 ↗InjuryMay 11, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO YEARS POST-OPERATION, THE PATIENT WAS REVISED DUE TO PAIN, SWELLING, AND FEMORAL IMPLANT LOOSENING. DURING THE REVISION SURGERY, BONE LOSS WAS NOTED. THE TIBIAL, FEMORAL, AND ARTICULAR SURFACE COMPONENTS WERE EXCHANGED WITHOUT COMPLICATIONS, AND THE PATELLA REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Pain; Swelling/ Edema
MAUDE report 25137453 ↗InjuryMay 11, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO YEARS POST-OPERATION, THE PATIENT WAS REVISED DUE TO PAIN, SWELLING, AND FEMORAL IMPLANT LOOSENING. DURING THE REVISION SURGERY, BONE LOSS WAS NOTED. THE TIBIAL, FEMORAL, AND ARTICULAR SURFACE COMPONENTS WERE EXCHANGED WITHOUT COMPLICATIONS, AND THE PATELLA REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Pain; Swelling/ Edema
MAUDE report 25137444 ↗InjuryJan 5, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THE PATIENT UNDERWENT A KNEE REVISION TO A TOTAL KNEE REPLACEMENT DUE TO LOOSENING AND SIGNIFICANT POLYETHYLENE WEAR. FOLLOWING AN INITIAL PARTIAL KNEE REPLACEMENT, SYMPTOMS DEVELOPED APPROXIMATELY A FEW MONTHS LATER, INCLUDING PAIN, DEFORMITY, LIMITED RANGE OF MOTION, WEAKNESS, AND INSTABILITY. A COMPUTED TOMOGRAPHY SCAN PERFORMED APPROXIMATELY SEVERAL MONTHS AFTER SYMPTOM ONSET SHOWED LUCENCY AT THE TIBIAL AND FEMORAL BONE INTERFACE. BLOODWORK WAS PERFORMED TO RULE OUT INFECTION. INTRA-OPERATIVELY DURING THE REVISION, FINDINGS INCLUDED SIGNIFICANT POLYETHYLENE WEAR, GROSS LOOSENING OF THE TIBIAL IMPLANT, ANTERIOR CRUCIATE LIGAMENT DEFICIENCY, AND FULL-THICKNESS CARTILAGE LOSS IN THE REMAINING COMPARTMENTS. A COMPUTED TOMOGRAPHY SCAN PERFORMED APPROXIMATELY ONE YEAR EARLIER SHOWED ONLY A MILD DEGREE OF DEGENERATIVE OSTEOARTHRITIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Deformity/ Disfigurement; Joint Laxity; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain
MAUDE report 23954708 ↗InjuryDec 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening
MAUDE report 23766252 ↗InjuryDec 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening
MAUDE report 23766250 ↗InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AND AMBULATION DIFFICULTIES APPROXIMATELY TWO YEARS AND TWO AND A HALF MONTHS POST IMPLANTATION. AT FOLLOW-UP VISIT A CORTISONE SHOT WAS OFFERED AND CELEBREX HAS BEEN PRESCRIBED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 23725888 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AND AMBULATION DIFFICULTIES APPROXIMATELY TWO YEARS AND TWO AND A HALF MONTHS POST IMPLANTATION. AT FOLLOW-UP VISIT A CORTISONE SHOT WAS OFFERED AND CELEBREX HAS BEEN PRESCRIBED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 23657463 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AND AMBULATION DIFFICULTIES APPROXIMATELY TWO YEARS AND TWO AND A HALF MONTHS POST IMPLANTATION. AT FOLLOW-UP VISIT A CORTISONE SHOT WAS OFFERED AND CELEBREX HAS BEEN PRESCRIBED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 23657450 ↗InjuryAug 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening; Osteolysis; Pain
MAUDE report 22913703 ↗InjuryJul 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening
MAUDE report 22554108 ↗InjuryJul 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS AND SIX MONTHS FOLLOWING THE INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE RIGHT-SIDED FEMORAL KNEE IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening
MAUDE report 22554105 ↗InjuryJun 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND INSTABILITY. APPROXIMATELY THREE YEARS AND 2 MONTHS POST THE INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE LOOSENING OF THE FEMORAL AND TIBIAL IMPLANTS. ALL THE COMPONENTS WERE REVISED WITHOUT ANY REPORTED COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Failure of Implant; Pain
MAUDE report 22132712 ↗InjuryJun 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND INSTABILITY. APPROXIMATELY THREE YEARS AND 2 MONTHS POST THE INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE LOOSENING OF THE FEMORAL AND TIBIAL IMPLANTS. ALL THE COMPONENTS WERE REVISED WITHOUT ANY REPORTED COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Failure of Implant; Pain
MAUDE report 22132695 ↗InjuryJun 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND INSTABILITY. APPROXIMATELY THREE YEARS AND 2 MONTHS POST THE INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE LOOSENING OF THE FEMORAL AND TIBIAL IMPLANTS. ALL THE COMPONENTS WERE REVISED WITHOUT ANY REPORTED COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Failure of Implant; Pain
MAUDE report 22132686 ↗InjuryApr 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Cyst(s); Decreased Appetite; Deformity/ Disfigurement; Failure of Implant; Fatigue; Joint effusion; Pain
MAUDE report 21760297 ↗InjuryApr 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY OF A LEFT KNEE FEMORAL COMPONENT ONE YEAR AND TEN MONTHS POST INITIAL ARTHROPLASTY DUE TO PAIN, FATIGUE, AND DIFFICULTY WITH DAILY WORK ACTIVITIES. MRI DEMONSTRATED A CYST-LIKE ABNORMALITY AND SIGNS COMPARABLE WITH HARDWARE LOOSENING. INTRA-OPERATIVELY A LARGE DEFECT TO THE MEDIAL FEMORAL CONDYLE WAS NOTED AS WELL AS GROSS LOOSENING OF THE FEMORAL COMPONENT CONFIRMED-THE TIBIAL SIDE WAS FOUND TO BE SOLID AND THEREFORE REMAINS IN PLACE. NO COMPLICATIONS WERE REPORTED, AND FURTHER DETAILS HAVE NOT BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Cyst(s); Decreased Appetite; Deformity/ Disfigurement; Failure of Implant; Fatigue; Joint effusion; Pain
MAUDE report 21760293 ↗InjuryMar 31, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY 1 YEAR AND 7 MONTHS POST INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO FEMORAL IMPLANT LOOSENING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 21730269 ↗InjuryMar 17, 2025Adverse 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: Ambulation or Postural Difficulties; Pain; Swelling/ Edema; Synovitis
MAUDE report 21618260 ↗InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Muscle/Tendon Damage; Necrosis; Pain
MAUDE report 21302088 ↗InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Muscle/Tendon Damage; Necrosis; Pain
MAUDE report 21302086 ↗InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Cyst(s); Inflammation; Muscle/Tendon Damage; Necrosis; Pain
MAUDE report 21292930 ↗
Other BONE CEMENT devices
- SMARTSET 3122-040Depuy (Ireland) · BONE CEMENT824 reports
- NA 3322-020Depuy (Ireland) · BONE CEMENT306 reports
- NA 3312-040Depuy (Ireland) · BONE CEMENT4 deaths258 reports
- NA 3332-040Depuy (Ireland) · BONE CEMENT4 deaths197 reports
- NA 5450-31-500Depuy (Ireland) · BONE CEMENT2 deaths168 reports
- NA 5450-32-500Depuy (Ireland) · BONE CEMENT1 death150 reports
- PALACOS® MV pro 80Heraeus Medical GmbH · Bone Cement2 recalls1 report
- PALACOS® R pro 80Heraeus Medical GmbH · Bone Cement2 recalls1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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