MALLORY/HEAD PRIMARY HIP SYSTEMRecalls & reported problems across all models
Biomet Orthopedics, LLC · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 20 models of MALLORY/HEAD PRIMARY HIP SYSTEM by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2021 and Dec 28, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Erosion” (2 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
MALLORY/HEAD PRIMARY HIP 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.
- Aug 21, 2019Terminated
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Z-0523-2020 · Root cause: Environmental control · names 19 of these models · Recall details · FDA record ↗
Most reported MALLORY/HEAD PRIMARY HIP SYSTEM problems
Device problems
- Material Erosion2
Patient problems
- Ambulation or Postural Difficulties2
- Balance Problems2
- Dizziness2
- Metal Related Pathology2
- Pain2
- Failure of Implant1
- Nausea1
MALLORY/HEAD PRIMARY HIP SYSTEM models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-104110Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-104111PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-104112Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-104113Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-104114Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-104115PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-104116PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-104117Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-104118PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-104119Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-124309Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-124310PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-124311PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-124312Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-124313Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-124314Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-124315Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-124316Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 21-124317Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall0 reports
- MALLORY/HEAD PRIMARY HIP SYSTEM 11-104209Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
Recent MALLORY/HEAD PRIMARY HIP SYSTEM adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 28, 2021Material Erosion; Material Erosion
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Balance Problems; Dizziness; Failure of Implant; Metal Related Pathology; Pain
MAUDE report 13098317 ↗InjurySep 28, 2021Material Erosion; Material Erosion
IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND SUBSEQUENTLY 5 YEARS LATER IS EXPERIENCING PAIN, LOSS OF BALANCE, DIZZINESS, ELEVATED METAL IONS, DIFFICULTY IN WALKING AND UPSET STOMACH DUE TO THE DETERIORATION AND FAILURE OF IMPLANT. NO REVISION HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Balance Problems; Dizziness; Metal Related Pathology; Nausea; Pain
MAUDE report 12543324 ↗
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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