Taperloc Complete Micro Primary Femoral 51-107110Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Taperloc Complete Micro Primary Femoral (35)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00880304513457), received between Apr 15, 2020 and Sep 1, 2026 — classified as 2 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 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
- Tear, Rip or Hole in Device Packaging3
- Device Contaminated During Manufacture or Shipping2
- Manufacturing, Packaging or Shipping Problem2
- Packaging Problem2
- Adverse Event Without Identified Device or Use Problem1
- Delivered as Unsterile Product1
- Difficult to Insert1
- Material Erosion1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Ambulation or Postural Difficulties2
- Fall1
- Hypersensitivity/Allergic reaction1
- Metal Related Pathology1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
- Pain1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551551 ↗MalfunctionDec 9, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759671 ↗InjuryAug 14, 2025Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST-IMPLANTATION, THE PATIENT IS EXPERIENCING MULTIPLE ISSUES: A METALLIC TASTE IN THE MOUTH AND HAS CORRESPONDING NICKEL ALLERGY; A RASH ON THEIR LEG; FEELINGS OF THEIR FEMUR SHIFTING; TWO ROUNDS OF ANTIBIOTIC TREATMENT AND IV ANTIBIOTICS FOR INFECTION; INABILITY TO WALK MUCH; TOES GO NUMB WHEN LAYING ON SIDE; HEART ATTACK LIKE SYMPTOMS; BACK PAIN; POTASSIUM AND MAGNESIUM INFUSIONS FOR UNKNOWN REASON MAKING THEM FEEL WORSE; ALLEGED METAL IN URINE THAT SURGEON THINKS IS A KIDNEY STONE; OTHER GREEN PARTICLES IN URINE SUSPECTED AS SUTURE PIECES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Unspecified Infection
MAUDE report 22809633 ↗MalfunctionJul 14, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE STERILE PACKAGING WAS FOUND DAMAGED WHILE INSPECTING STOCK. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22503419 ↗MalfunctionApr 24, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING WAS DAMAGED DURING INSPECTION OF CIRCULATED ITEMS. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898526 ↗MalfunctionJul 29, 2024Difficult to Insert; Difficult to Insert
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19850395 ↗MalfunctionJul 8, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED, BY THE DISTRIBUTORSHIP, THAT DURING INCOMING INSPECTION, THE STERILE PACKAGING WAS FOUND TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19690333 ↗InjuryApr 14, 2023Migration; Migration
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Fall
MAUDE report 16742091 ↗MalfunctionMar 7, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16500361 ↗MalfunctionFeb 18, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE INNER PACKAGE WAS DAMAGED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13560169 ↗MalfunctionMay 3, 2021Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11761276 ↗MalfunctionApr 29, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION ON REPORTED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10009318 ↗MalfunctionApr 15, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED DEBRIS WAS FOUND IN THE STERILE PACKAGING. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9962660 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
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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