NA 6250-65-40Recalls & reported problems
Zimmer, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer hip implant, a porous uncemented metal-and-polymer hip prosthesis, appears in 43 adverse event reports. Most describe the implant loosening or shifting, breaking, or sitting poorly in the socket, leading to pain, leg-length differences, dislocation, and repeat revision surgery; some describe infection around the implant. There were34 injuries and no deaths.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00889024119840), received between Dec 4, 2019 and May 15, 2026 — classified as 34 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (16 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
- Loosening of Implant Not Related to Bone-Ingrowth16
- Fracture8
- Migration8
- Adverse Event Without Identified Device or Use Problem7
- Activation, Positioning or Separation Problem1
- Device Dislodged or Dislocated1
- Loss of or Failure to Bond1
- Material Deformation1
Patient problems
- Failure of Implant13
- No Clinical Signs, Symptoms or Conditions10
- Pain9
- Aseptic loosening4
- Deformity/ Disfigurement4
- Unequal Limb Length4
- Foreign Body In Patient3
- Osteopenia/ Osteoporosis3
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, THE PATIENT PRESENTED WITH SEPTIC SHOCK DUE TO MRSA INFECTION IN THE HIP. THEY HAD FEVERS, DIFFICULTY WALKING, SWELLING, ABSCESS, AND POSITIVE CULTURES FOR MRSA AND SEPTIC SHOCK. THE HEAD WAS EXCHANGED IN AN I&D PROCEDURE BEFORE THE STAGE ONE REVISION ONE MONTH LATER. OP RECORDS NOTE PURULENT FLUID, LARGE FASCIAL DEHISCENCE. ALL COMPONENTS WERE REPLACED WITH A CEMENT SPACER DURING STAGE ONE WITHOUT COMPLICATIONS. THE STAGE TWO REVISION TOOK PLACE FOUR MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Abscess; Ambulation or Postural Difficulties; Bacterial Infection; Medical device site infection; Purulent Discharge; Scar Tissue; Sepsis; Septic Shock; Swelling/ Edema; Wound Dehiscence
MAUDE report 25183724 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, THE PATIENT PRESENTED WITH SEPTIC SHOCK DUE TO MRSA INFECTION IN THE HIP. THEY HAD FEVERS, DIFFICULTY WALKING, SWELLING, ABSCESS, AND POSITIVE CULTURES FOR MRSA AND SEPTIC SHOCK. THE HEAD WAS EXCHANGED IN AN I&D PROCEDURE BEFORE THE STAGE ONE REVISION ONE MONTH LATER. OP RECORDS NOTE PURULENT FLUID, LARGE FASCIAL DEHISCENCE. ALL COMPONENTS WERE REPLACED WITH A CEMENT SPACER DURING STAGE ONE WITHOUT COMPLICATIONS. THE STAGE TWO REVISION TOOK PLACE FOUR MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Abscess; Ambulation or Postural Difficulties; Bacterial Infection; Medical device site infection; Purulent Discharge; Scar Tissue; Sepsis; Septic Shock; Swelling/ Edema; Wound Dehiscence
MAUDE report 25183690 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INSTABILITY, RECURRENT DISLOCATIONS, AND IMPINGEMENT FROM POOR POSITIONING OF IMPLANTS. THE SURGEON ATTRIBUTED THE RECURRENT DISLOCATION TO POOR CUP PLACEMENT. THE TROCHANTERIC CLAW HAD ANTERIOR FIXATION RESULTING IN TISSUE IMPINGEMENT. DURING THE REVISION, A COMPETITOR CUP WAS CEMENTED INTO THE EXISTING CUP; THE HEAD AND LINER WERE EXCHANGED; AND THE STEM AND CLAW WERE RETAINED WITH SOME TISSUE AROUND THE GREATER TROCHANTER DEBRIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement; Joint Laxity; Pain
MAUDE report 24455798 ↗InjuryDec 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening
MAUDE report 23811676 ↗InjuryNov 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING. THE CUP AND SCREWS WERE EXPLANTED.
Patient problems: Aseptic loosening
MAUDE report 23616756 ↗InjurySep 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A SECOND REVISION ON AN UNKNOWN DATE DUE TO INSUFFICIENT FIXATION OF THE CUP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening
MAUDE report 22991046 ↗InjurySep 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A SECOND REVISION ON AN UNKNOWN DATE DUE TO INSUFFICIENT FIXATION OF THE CUP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening
MAUDE report 22991037 ↗InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT REPORTED TENDERNESS OVER THE GREATER TROCHANTER CONSISTENT WITH BURSITIS APPROXIMATELY 1 YEAR LATER. THE PATIENT WAS USING CANES TO AMBULATE AND EXPERIENCED A MODERATE LIMP. THE SURGEON PROVIDED A CORTISONE INJECTION AND A TOPICAL ANTI-INFLAMMATORY CREAM, AND THE ISSUES WERE REPORTEDLY RESOLVED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bursitis; Pain
MAUDE report 22884383 ↗MalfunctionJul 30, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE ACETABULAR SCREW HAD METAL SHAVING PRESENT ON HEAD OF SCREW. THERE WAS NO PATIENT IMPACT, NO MEDICAL/SURGICAL INTERVENTIONS AND NO SURGICAL DELAY. THERE WERE NO CONTRIBUTING FACTORS TO THE EVENT. ADDITIONALLY, THERE WAS NO FOREIGN BODY RETAINED IN THE PATIENT. THE SCREW WAS DISCARDED BY THE USER FACILITY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22668789 ↗InjuryJul 22, 2025Fracture; Fracture
IT WAS REPORTED THE SCREWS BROKE DURING INSERTION. THE SURGEON COMPLETED THE SURGERY USING SHORT SCREWS WITHOUT FORCING THEM. THE BROKEN TIP OF THE SCREW WAS LEFT INSIDE THE PATIENT¿S BODY AT THE SURGEON¿S DISCRETION.
Patient problems: Foreign Body In Patient
MAUDE report 22564620 ↗InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN, SWELLING, BURNING SENSATION AND HAS A NICKEL ALLERGY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema
MAUDE report 21228370 ↗InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Pain
MAUDE report 20820287 ↗InjurySep 11, 2024Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS POST IMPLANTATION OF A LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO HIP PAIN AND CUP MIGRATION MEDIALLY INTO THE PELVIS. THERE ARE NO KNOWN CONTRIBUTING CONDITIONS EXCEPT FOR POOR BONE QUALITY. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: Failure of Implant; Pain
MAUDE report 20189498 ↗MalfunctionJun 5, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING THE SURGERY THE SURGEON ATTEMPTED TO INSERT THE SCREW AND IT BENT. 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 19468954 ↗MalfunctionMar 11, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18877252 ↗MalfunctionFeb 20, 2024
BONE SCREW BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18739446 ↗InjuryDec 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS AFTER A SECOND STAGE REVISION DUE TO ACETABULAR LOOSENING. THE HEAD, SHELL, LINER, AND AUGMENT WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 18344633 ↗InjuryDec 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 18344625 ↗MalfunctionDec 14, 2023Fracture; Fracture
IT WAS REPORTED WHILE SURGEON WAS IMPLANTING THE SCREW THROUGH A G7 SHELL, THE OUTER PORTION OF THE SCREW HEAD SHEARED OFF AND THE SCREW WENT COMPLETELY THROUGH THE ACETABULAR COMPONENT. THE DOCTOR WAS ABLE TO REMOVE THE SHELL, THEN THE SCREW, AND TRY AGAIN WITH A NEW SCREW. THE METAL SHARD FROM THE SCREW WAS RECOVERED AND REMOVED FROM THE PATIENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18328884 ↗InjuryDec 1, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT WAS BORN WITH HIP DYSPLASIA. THE PATIENT¿S CUP STARTED TO WEAR AND WAS REVISED. ONE YEAR POST IMPLANTATION, THE PATIENT FELL, AND THE CUP WAS FOUND TO BE LOOSE. THE SURGEON RECOMMENDED A CUSTOM IMPLANT.
Patient problems: Fall
MAUDE report 18245616 ↗InjuryNov 29, 2023Migration; Migration
IT WAS REPORTED A PATIENT HAD A REVISION OF A RIGHT HIP PROSTHESIS. SUBSEQUENTLY, APPROXIMATELY TWO WEEKS LATER, RADIOGRAPHIC IMAGING DISPLAYED DISSOCIATION OF THE CUP FROM THE PELVIS AND ¿HUGE¿ PELVIC DEFECTS. UPON FOLLOW-UP, THE PATIENT REPORTS HAVING SEVERE PAIN AND ASSESSMENT INDICATED THAT THE RIGHT LEG WAS SHORTENED. A PMI PRODUCT IS CURRENTLY BEING PLANNED FOR THE PATIENT¿S NEXT REVISION.
Patient problems: Deformity/ Disfigurement; Pain; Unequal Limb Length
MAUDE report 18231790 ↗InjuryNov 29, 2023Migration; Migration
IT WAS REPORTED A PATIENT HAD A REVISION OF A RIGHT HIP PROSTHESIS. SUBSEQUENTLY, APPROXIMATELY TWO WEEKS LATER, RADIOGRAPHIC IMAGING DISPLAYED DISSOCIATION OF THE CUP FROM THE PELVIS AND ¿HUGE¿ PELVIC DEFECTS. UPON FOLLOW-UP, THE PATIENT REPORTS HAVING SEVERE PAIN AND ASSESSMENT INDICATED THAT THE RIGHT LEG WAS SHORTENED. A PMI PRODUCT IS CURRENTLY BEING PLANNED FOR THE PATIENT¿S NEXT REVISION.
Patient problems: Deformity/ Disfigurement; Pain; Unequal Limb Length
MAUDE report 18231783 ↗InjuryNov 29, 2023Migration; Migration
IT WAS REPORTED A PATIENT HAD A REVISION OF A RIGHT HIP PROSTHESIS. SUBSEQUENTLY, APPROXIMATELY TWO WEEKS LATER, RADIOGRAPHIC IMAGING DISPLAYED DISSOCIATION OF THE CUP FROM THE PELVIS AND ¿HUGE¿ PELVIC DEFECTS. UPON FOLLOW-UP, THE PATIENT REPORTS HAVING SEVERE PAIN AND ASSESSMENT INDICATED THAT THE RIGHT LEG WAS SHORTENED. A PMI PRODUCT IS CURRENTLY BEING PLANNED FOR THE PATIENT¿S NEXT REVISION.
Patient problems: Deformity/ Disfigurement; Pain; Unequal Limb Length
MAUDE report 18231754 ↗InjuryNov 29, 2023Migration; Migration
IT WAS REPORTED A PATIENT HAD A REVISION OF A RIGHT HIP PROSTHESIS. SUBSEQUENTLY, APPROXIMATELY TWO WEEKS LATER, RADIOGRAPHIC IMAGING DISPLAYED DISSOCIATION OF THE CUP FROM THE PELVIS AND ¿HUGE¿ PELVIC DEFECTS. UPON FOLLOW-UP, THE PATIENT REPORTS HAVING SEVERE PAIN AND ASSESSMENT INDICATED THAT THE RIGHT LEG WAS SHORTENED. A PMI PRODUCT IS CURRENTLY BEING PLANNED FOR THE PATIENT¿S NEXT REVISION.
Patient problems: Deformity/ Disfigurement; Pain; Unequal Limb Length
MAUDE report 18231731 ↗InjurySep 22, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17799149 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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