Biomet Knee SystemRecalls & reported problems across all models
Biomet Orthopedics, LLC · 72 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 137
- Deaths reported
- 0
- Injuries reported
- 121
- Recalls
- 1
We found 72 models of Biomet Knee System by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 137 adverse event reports in the FDA's MAUDE database, received between Sep 9, 2019 and Jun 24, 2026 — classified as 121 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (25 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Biomet Knee System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 18, 2018Terminated
One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
Z-2177-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Biomet Knee System problems
Device problems
- Adverse Event Without Identified Device or Use Problem65
- Loosening of Implant Not Related to Bone-Ingrowth25
- Migration16
- Fracture11
- Difficult to Insert6
- Insufficient Device Problem Information5
- Noise, Audible4
- Packaging Problem4
Patient problems
- Pain82
- Ambulation or Postural Difficulties27
- Failure of Implant23
- Swelling/ Edema20
- Loss of Range of Motion19
- No Clinical Signs, Symptoms or Conditions17
- Swelling12
- Scar Tissue11
Biomet Knee System models
72 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIOMET KNEE SYSTEM 141215Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall3 reports
- Biomet® Knee System 141205PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- BIOMET KNEE SYSTEM 141314PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- Biomet® Knee System 141233PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- BIOMET KNEE SYSTEM 141233PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- BIOMET KNEE SYSTEM 141234PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- Biomet® Knee System 141234PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- BIOMET KNEE SYSTEM 141224PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- BIOMET KNEE SYSTEM 141231PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- Biomet® Knee System 141222PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- Biomet® Knee System 141232Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer3 reports
- Biomet® Knee System 141235PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Biomet® Knee System 141232Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive3 reports
- BIOMET KNEE SYSTEM 141222PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- BIOMET KNEE SYSTEM 11-150840PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Biomet Knee System 141320PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- BIOMET KNEE SYSTEM 141232PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- BIOMET KNEE SYSTEM 141223PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- Biomet® Knee System 148306PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Biomet® Knee System 148309PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Biomet® Knee System 141483Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer2 reports
- Biomet® Knee System 141211Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer2 reports
- Biomet® Knee System 141212PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- Biomet® Knee System 141213Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive2 reports
- Biomet® Knee System 141224PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Biomet® Knee System 141231PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- Biomet® Knee System 141233Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive2 reports
- Biomet® Knee System 141235PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- BIOMET KNEE SYSTEM 141212PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 141616PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 141491Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 report
- Biomet® Knee System 141612PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 141620PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- BIOMET KNEE SYSTEM 11-150828PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Biomet® Knee System 141658PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- BIOMET KNEE SYSTEM 11-150842PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- BIOMET KNEE SYSTEM 141216PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- BIOMET KNEE SYSTEM 141213PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Biomet Knee System 141264PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- BIOMET KNEE SYSTEM 141235PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- BIOMET KNEE SYSTEM 11-150844PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- BIOMET KNEE SYSTEM 11-150826PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Biomet Knee System 141263PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Biomet Knee System 141316PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet Knee System 141318PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- BIOMET KNEE SYSTEM 141225PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- BIOMET KNEE SYSTEM 11-150838PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- BIOMET KNEE SYSTEM 141221PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- BIOMET KNEE SYSTEM 141481PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 141489PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Biomet® Knee System 145008PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 145020PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 148162PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 148323PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 148304PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 148310PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 148293PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 148297PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 148318PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 148329PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 141481Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 report
- Biomet® Knee System 141214PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 141215PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 141216PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 141223Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
- Biomet® Knee System 141225PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Biomet® Knee System 141226PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Biomet® Knee System 141236PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Biomet® Knee System 11-150828PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Biomet® Knee System 141213PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Biomet® Knee System 141234PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Biomet® Knee System 141266Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
Recent Biomet Knee System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN AND WAS REVISED APPROXIMATELY 6 YEARS POST-OP. THE SURGEON NOTED THAT THE POLY APPEARED TO HAVE DISLODGED OR MOVED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 25611921 ↗InjuryApr 7, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT BROKE INTO 2 PIECES DURING SURGERY. DUE TO A LOW INVENTORY, THE IMPLANT WAS REINSERTED AFTER BEING BONDED BACK TOGETHER WITH BONE CEMENT. THERE WAS NO SURGICAL DELAY AND THE SURGICAL TECHNIQUE HAD BEEN UTILIZED. THERE ARE NO PLANS FOR A REVISION AT THIS TIME. THE PATIENT IS NOT EXPERIENCING ANY SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799689 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO PAIN, ARTHROFIBROSIS, AND ANKYLOSIS. SUBSEQUENTLY, THE PATIENT CONTINUES TO REPORT UNRESOLVED EXTREME PAIN TO LEFT KNEE, AND NO ADDITIONAL INTERVENTIONS HAVE BEEN PERFORMED. PATIENT STATED THE BONE CEMENT THAT WAS USED WITH HER IMPLANTS WAS RECALLED DUE TO BEING TOXIC. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Ankylosis; Arthrofibrosis; Pain
MAUDE report 24640524 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO PAIN, ARTHROFIBROSIS, AND ANKYLOSIS. SUBSEQUENTLY, THE PATIENT CONTINUES TO REPORT UNRESOLVED EXTREME PAIN TO LEFT KNEE, AND NO ADDITIONAL INTERVENTIONS HAVE BEEN PERFORMED. PATIENT STATED THE BONE CEMENT THAT WAS USED WITH HER IMPLANTS WAS RECALLED DUE TO BEING TOXIC. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Ankylosis; Arthrofibrosis; Pain
MAUDE report 24640505 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE MONTH FOLLOWING A LEFT TOTAL KNEE ARTHROPLASTY WAS PERFORMED, A PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF LEFT LEG DVT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Thromboembolism
MAUDE report 24640465 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE MONTH FOLLOWING A LEFT TOTAL KNEE ARTHROPLASTY WAS PERFORMED, A PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF LEFT LEG DVT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Thromboembolism
MAUDE report 24640453 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Swelling/ Edema
MAUDE report 24498404 ↗MalfunctionFeb 12, 2026Difficult to Insert
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE LOCKING BAR ON AN ARTICULAR SURFACE WAS DIFFICULT TO ASSEMBLE WITH THE TIBIAL TRAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321781 ↗InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND STIFFNESS APPROXIMATELY SIX (6) MONTHS FOLLOWING KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 23943969 ↗InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SEVEN YEARS SEVEN AND A HALF MONTHS POST IMPLANTATION DUE TO COLLAPSE OF THE IMPLANT ON ONE SIDE CAUSING PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 23933825 ↗InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SEVEN YEARS SEVEN AND A HALF MONTHS POST IMPLANTATION DUE TO COLLAPSE OF THE IMPLANT ON ONE SIDE CAUSING PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 23933817 ↗InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. FOLLOWING THE PROCEDURE, THE PATIENT CONTINUED HAVING PAIN AND NEUROPATHY IN THE LEG WITH LIMITED RANGE OF MOTION. DIAGNOSTICS REVEALED DAMAGE TO THE PERONEAL NERVE RESULTING IN FOOT DROP AND DIFFICULTY AMBULATING. PHYSICAL EXAM REVEALED A PALPABLE BAKER¿S CYST, AND X-RAYS SHOWED EXCESSIVE TIBIAL SLOPE. SUBSEQUENTLY, APPROXIMATELY FOUR (4) MONTHS POST-IMPLANTATION, A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO ANKYLOSIS AND ARTHROFIBROSIS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Ankylosis; Arthrofibrosis; Cyst(s); Loss of Range of Motion; Nerve Damage; Neuropathy; Pain; Swelling/ Edema
MAUDE report 23537688 ↗InjuryAug 28, 2025Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN, SWELLING, JOINT LAXITY, LOOSENING, AND MUSCLE WEAKNESS APPROXIMATELY FOUR YEARS POST IMPLANTATION. AN EXAM BY A PHYSICIAN FOUND THE KNEE TO BE WEAK AND LOOSE. A RADIOACTIVE SCAN WAS ORDERED AND COMPLETED. DAMAGE WAS FOUND IN THE KNEE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Aseptic loosening; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema
MAUDE report 22913554 ↗MalfunctionJul 29, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT WHEN THE PACKAGING WAS OPENED FOR THE TIBIAL COMPONENT, THE IMPLANT APPEARED TO HAVE STAINING ON THE SURFACE. ANOTHER TIBIAL PLATE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22648163 ↗InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT REVISION SURGERY DUE TO AN UNSPECIFIED INFECTION IN THE RIGHT KNEE APPROXIMATELY ONE MONTH POST IMPLANTATION. ALL IMPLANTS WERE REMOVED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Unspecified Infection
MAUDE report 22171370 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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