System 12Recalls & reported problems across all models

We found 8 models of System 12 by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Mar 1, 2017 and Mar 20, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

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

System 12 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.

1. Jul 30, 2026Open, Classified

   Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

   Z-3201-2026 · Root cause: Process change control · Recall details · FDA record ↗

2. Dec 1, 2023Open, Classified

   Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

   Z-0905-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Dec 1, 2023Open, Classified

   Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

   Z-0904-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported System 12 problems

System 12 models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• System 12 6302-6-107

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 recall0 reports
• System 12 6302-6-307

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 recall0 reports
• System 12 6302-H-632

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  1 recall0 reports
• System 12 6302-5-075

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• System 12 6302-5-062

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  1 report
• System 12 6302-5-105

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• System 12 6352-5-073

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 report
• System 12 6352-5-104

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report

Recent System 12 adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. A SCREW AND POLY INSERT WERE IMPLANTED. UPDATE 23/FEBRUARY/2023: PATIENT WAS REVISED DUE TO WEAR OF THE POLY. THE POLY AND HEAD WERE REMOVED AND A NEW POLY IMPLANTED WITH THE THOUGHT THAT A FEMORAL HEAD TO FIT IN IT WOULD BE AVAILABLE. A FEMORAL HEAD FOR THE LINER WAS NOT AVAILABLE, SO THEY WASTED THE LINER, IMPLANTED A 28MM LINER, AND RE-IMPLANTED THE EXPLANTED HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 16572347 ↗
• InjuryNov 21, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO MINOR INSTABILITY AND PAIN. A 28 +4 METAL HEAD AND SYSTEM 12 LINER WERE REVISED TO A 32MM BIOLOX HEAD WITH +4 SLEEVE AND A SYSTEM 12 10° LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15840846 ↗
• InjuryNov 3, 2021Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO ECCENTRIC WEAR OF THE POLY LINER AND INSTABILITY. A HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 12749825 ↗
• InjuryDec 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO CHRONIC DISLOCATIONS OF THE HEAD FROM THE POLY LINER. SURGEON REPORTED THE SHELL APPEARED SLIGHTLY RETROVERTED. THE SHELL, POLY LINER, AND FEMORAL HEAD WERE REVISED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9513168 ↗
• InjuryNov 15, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO MULTIPLE DISLOCATIONS AND SUSPECTED LINER WEAR. THE PATIENT'S HEAD AND LINER WERE REVISED. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9329153 ↗
• InjuryMar 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD REVISION OF RIGHT HIP.

  Patient problems: Injury

  MAUDE report 6370415 ↗

Other Howmedica Osteonics Corp. products

• Triathlon608 models · 3,524 reports · 15 recalls
• Scorpio107 models · 113 reports · 28 recalls
• Trident160 models · 1,280 reports · 2 recalls
• Accolade57 models · 1,228 reports
• Duracon58 models · 65 reports · 16 recalls
• LFIT23 models · 852 reports
• TRIDENT II42 models · 188 reports · 12 recalls
• INSTRUMENT131 models · 290 reports · 7 recalls