Mectacer Biolox Delta Femoral Ball HeadRecalls & reported problems across all models
Medacta International SA · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 551
- Deaths reported
- 0
- Injuries reported
- 549
- Recalls
- 0
We found 15 models of Mectacer Biolox Delta Femoral Ball Head by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 551 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2017 and Sep 9, 2026 — classified as 549 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (175 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. 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
Most reported Mectacer Biolox Delta Femoral Ball Head problems
Device problems
- Device Appears to Trigger Rejection175
- Device Dislodged or Dislocated152
- Adverse Event Without Identified Device or Use Problem96
- Appropriate Device Problem Term/Code Not Available91
- Inadequacy of Device Shape and/or Size12
- Insufficient Device Problem Information7
- Unstable6
- Microbial Contamination of Device5
Patient problems
- Unspecified Infection162
- Medical device site infection117
- Joint Dislocation105
- Implant Pain38
- Pain38
- Joint Laxity34
- Unequal Limb Length26
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available18
Mectacer Biolox Delta Femoral Ball Head models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Mectacer Biolox Delta Femoral Ball Head 01.29.209Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented109 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.208Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented92 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.204Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented62 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.210Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented48 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.205Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented40 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.202Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented36 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.206Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented32 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.201Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented31 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.213Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented29 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.203Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented22 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.212Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented18 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.211Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented12 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.214Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented10 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.215Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented8 reports
- Mectacer Biolox Delta Femoral Ball Head 01.29.207Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
Recent Mectacer Biolox Delta Femoral Ball Head adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Device Dislodged or Dislocated
The patient had pain due to joint luxation; the head came off the liner, and the cause is unknown. There was no indication of trauma or fall. At about 1 month and a half post-primary. The surgeon revised the two-hole Acetabular shell to an Mpact DM Acetabular shell D 50, revised the 32mm Biolox Head S to a 28mm Biolox head L, and revised the Flat PE HC liner D 32/D to a Double Mobility HC Liner D 28/DME. The surgery was completed successfully.
Patient problems: Implant Pain; Joint Dislocation
MAUDE report 50692309 ↗InjurySep 9, 2026Device Dislodged or Dislocated
At about 3 days after the primary, the patient came in presenting pain due to dislocation of the head from the liner and the cause is unknown. The surgeon revised theFlat PE HC linerD 36/Eto a Hooded PE HC liner D 36/E and theMECTACER Head Biolox Delta D 36 12/14-Mto a Biolox head L. The surgery was completed successfully.
Patient problems: Implant Pain; Joint Dislocation
MAUDE report 50692300 ↗InjurySep 9, 2026Device Dislodged or Dislocated
The patient underwent primary hip surgery on (b)(6) 2024. Prior to the primary surgery, the patient had sustained a pelvic fracture, which had already healed.Two years and four months after the primary surgery, the patient experienced an anterior dislocation. An open revision was considered but was ultimately deemed unnecessary, as the surgeon successfully performed a closed reduction. No implant components were exchanged. To date, no further dislocation or other related event has been reported.
Patient problems: Implant Pain; Joint Dislocation
MAUDE report 50692267 ↗InjurySep 1, 2026Device Appears to Trigger Rejection
Patient problems: Medical device site infection
MAUDE report 50543249 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Implant Pain; Joint Laxity
MAUDE report 50543241 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection
Revision surgery at about 20 days from primary due to infection.The surgeon performed a washout and revised the head and liner. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50114125 ↗InjuryJul 9, 2026Device Dislodged or Dislocated
THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE HEAD AND LINER AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. AT ABOUT 20 DAYS FROM PRIMARY THE SURGEON REVISED THE 36MM BIOLOX DELTA HEAD S TO A 28MM BIOLOX OPTION HEAD WITH SLEEVE L, AND REVISED THE FLAT PE HC LINER D 36/F TO A DOUBLE MOBILITY HC LINER D 28/DMF WITH DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 25763498 ↗InjuryJul 9, 2026Device Appears to Trigger Rejection
REVISION SURGERY AFTER 1 MONTH FROM THE MEDACTA PRIMARY DUE TO INFECTION.
Patient problems: Medical device site infection
MAUDE report 25763492 ↗InjuryJul 8, 2026Device Appears to Trigger Rejection
REVISION SURGERY AFTER 2 MONTHS FROM PRIMARY DUE TOINFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND THE HEAD AND THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: Medical device site infection
MAUDE report 25747751 ↗InjuryJul 8, 2026Device Appears to Trigger Rejection
THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 9 YEARS AND 6 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT, REVISED THE 36/G FLAT PE HC LINER TO A 40/G FLAT PE HC LINER, AND REVISED 36MM BIOLOX DELTA HEAD M TO A 40MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25747744 ↗InjuryJul 8, 2026Device Appears to Trigger Rejection
AT ABOUT 1 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLAT PE HC LINER D 40/F TO A FACE CHANGING 10° PE HC LINER D 40/G AND THE 40MM BIOLOX HEAD M TO A SIZE S. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25747742 ↗InjuryJul 6, 2026Device Appears to Trigger Rejection
AT ABOUT 1 MONTH FROM THE PRIMARY,THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON OBSERVED WOUND WEEPING AND PERFORMED A WASHOUT. DURING THE PROCEDURE, THE HEAD WAS REVISED TO A HEAD WITH A SLEEVE, AND THE LINER WAS REVISED TO A SAME-SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25714724 ↗InjuryJul 1, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER ABOUT 2 YEARS AND 6 MONTHS FROM PRIMARY.THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE 40MM BIOLOX HEAD M TO A 40MM BIOLOX OPTION HEAD WITH SLEEVE, AND REVISED THE FLAT PE HC LINER D 40/G TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25677104 ↗InjuryJun 30, 2026Device Dislodged or Dislocated
REVISION SURGERY DUE TO JOINT LUXATION AFTER ABOUT 8 MONTHS FROM PRIMARY SURGERY. THE SURGEON REVISED THE 40MM BIOLOX DELTA HEAD S TO A 28MM BIOLOX DELTA HEAD M AND REVISED THE FLAT PE HC LINER D 40/F TO A CONSTRAINED 10° PE LINER D 28/F. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 25663306 ↗InjuryJun 17, 2026Device Appears to Trigger Rejection
ON (B)(6) 2026, THE PATIENT HAD PRIMARY RIGHT HIP SURGERY WITH MEDACTA PRODUCTS. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE 32 MM BIOLOX S HEAD AND D 32/D LINER TO A SAME SIZE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY [MDR (B)(4)]. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO CONTINUED SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE CUP, LINER, HEAD, AND STEM AND REPLACED THEM WITH ANTIBIOTIC SPACERS TO TREAT THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25528760 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
- GMK Revision Total Knee System71 models · 304 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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