Z1 Hip SystemRecalls & reported problems across all models

We found 17 models of Z1 Hip System by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2025 and Aug 27, 2026 — classified as 6 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (8 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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

Z1 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.

1. Feb 12, 2025Open, Classified

   There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

   Z-1329-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Z1 Hip System problems

Z1 Hip System models

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

• Z1™ Hip System 611777612

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 recall2 reports
• Z1™ Hip System 611201010

  Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
  3 reports
• Z1™ Hip System 611201020

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• Z1™ Hip System 611201040

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  2 reports
• Z1™ Hip System 611201050

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  2 reports
• Z1™ Hip System 611201060

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  2 reports
• Z1™ Hip System 611202040

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  2 reports
• Z1™ Hip System 611201000

  Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
  1 report
• Z1™ Hip System 611201030

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  1 report
• Z1™ Hip System 611201070

  Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
  1 report
• Z1™ Hip System 611202010

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• Z1™ Hip System 611202030

  Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
  1 report
• Z1™ Hip System 611202070

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 report
• Z1® Hip System 612202030

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 report
• Z1™ Hip System 611777510

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• Z1™ Hip System 611889060

  Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
  1 report
• Z1™ Hip System 611889120

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report

Recent Z1 Hip System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Malposition of Device

  It was reported that during implantation the collarless cemented stem sat approximately 2¿3 mm below the planned preparation level. There was no known impact to the patient. It was reported no further information available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50481869 ↗
• MalfunctionAug 6, 2026Sharp Edges

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164862 ↗
• MalfunctionMay 27, 2026Positioning Failure; Nonstandard Device

  IT WAS REPORTED THAT DURING A RIGHT HIP PROCEDURE, THE FEMUR WAS BROACHED TO A SIZE 2 AND THE SIZE 2 STEM IMPLANT WENT RIGHT INTO THE FEMUR BY HAND WITHOUT IMPACTION. THE SURGEON DID NOT WANT TO BROACH UP BIGGER SO OPENED A SECOND STEM OF THE SAME SIZE. THE SECOND STEM SEATED APPROPRIATELY AND WAS IMPACTED WITH GREAT RESULT. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25310900 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  No additional information available for the reported event.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 25215914 ↗
• MalfunctionMay 8, 2026Positioning Failure; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON BROACHED THE RIGHT FEMUR TO A SIZE 6 AND THE BROACH WAS TIGHT. THE SIZE 6 STEM WAS THEN LOOSE. STEM WAS NOT USED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123433 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT TWO WEEKS POST-IMPLANTATION, THE PATIENT PRESENTED WITH SLOW WOULD HEALING AND WAS PRESCRIBED AN ANTIBIOTIC. AT THE NEXT FOLLOW-UP, THE ISSUE WAS RESOLVED, AND ALL COMPONENTS REMAIN IMPLANTED WITHOUT COMPLICATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Impaired Healing

  MAUDE report 24582050 ↗
• MalfunctionDec 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE BROACH BROKE OFF. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717146 ↗
• InjuryNov 19, 2025Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT THE CALCAR CRACKED UPON IMPLANTATION. NO KNOWN CONSEQUENCES OR IMPACT ON THE PATIENT.

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592429 ↗
• MalfunctionOct 20, 2025Difficult to Insert; Product Quality Problem; Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT DURING A LEFT HIP PROCEDURE, THE STEM COULD NOT BE FULLY SEATED AND THE STEM SAT PERCHED AFTER IMPLANTATION. SURGEON BELIEVES THE COATING ON THE STEM IS TOO THICK. THERE WAS NO ADDITIONAL BROACHING CONDUCTED. THE STEM WAS IMPLANTED WITH NO FURTHER INTERVENTION MADE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335458 ↗
• MalfunctionOct 20, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON WAS NOT COMFORTABLE WITH THE PPS COATING THICKNESS. THE STEM WAS REMOVED AND MANUALLY BROACHED AND THEN THE SURGEON REINSERTED THE STEM. MINIMAL PERCHED WAS ACHIEVED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335378 ↗
• MalfunctionOct 15, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FINAL STEM IMPLANTATION PERCHED A COUPLE MILLIMETERS. THE SURGEON NOTED THAT THE PPS COATING IS THICK AND NEEDS TO BE REDUCED TO ALLOW ACCURATE 1:1 BROACH TO STEM. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292732 ↗
• MalfunctionSep 19, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THE Z1 STEM WAS PERCHED AND IS A REPEATED EVENT. THE SURGEON FEELS THE STEM TO BROACH RATIO IS INACCURATE REGARDING THE PPS COATING. THE Z1 COATING IS TOO THICK AND DOES NOT ALLOW FOR TRUE SEATING OF THE BROACH. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094969 ↗
• MalfunctionSep 19, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THE Z1 STEM WAS PERCHED AND IS A REPEATED EVENT. THE SURGEON FEELS THE STEM TO BROACH RATIO IS INACCURATE REGARDING THE PPS COATING. THE Z1 COATING IS TOO THICK AND DOES NOT ALLOW FOR TRUE SEATING OF THE BROACH. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094962 ↗
• MalfunctionSep 10, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE Z1 STEM PERCHED AND HAS BEEN A REPETITIVE RESULT WITH ALMOST EVERY Z1 STEM. THE SURGEON COMPLAINED THAT THE PPS COATING IS TOO THICK, AND DESIGNERS/ENGINEERS NEED TO REDUCE THE THICKNESS OF THE PPS COATING TO ALLOW FOR TRUE 1:1 BROACHING TO STEM RATIO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019213 ↗
• MalfunctionSep 9, 2025Positioning Failure; Positioning Failure

  NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003204 ↗

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