NA 6250-65-35Recalls & reported problems
Zimmer, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer hip replacement component is a metal-on-polymer hip prosthesis used in total hip arthroplasty. The 48 reports mostly describe hip pain, the implant loosening or shifting, broken parts including a fractured screw and bone fracture around the socket, and infection including one case of MRSA septic shock;35 reports describe injuries and no deaths. There are no recalls naming this device. Reports in the last 12 months fell to 3 from 17 the prior year.
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
- 48
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00889024119833), received between May 31, 2019 and May 15, 2026 — classified as 35 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (10 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem18
- Loosening of Implant Not Related to Bone-Ingrowth10
- Fracture9
- Positioning Failure6
- Migration4
- Device Contaminated During Manufacture or Shipping1
- Insufficient Device Problem Information1
- Malposition of Device1
Patient problems
- Pain15
- No Clinical Signs, Symptoms or Conditions13
- Bursitis6
- Aseptic loosening5
- Foreign Body In Patient4
- Unequal Limb Length4
- Unspecified Infection4
- Failure of Implant3
Recent adverse event reports
The 25 most recent of 48 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 25183740 ↗InjuryDec 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE ELDERLY PATIENT WAS REVISED APPROXIMATELY 1 (ONE) YEAR AFTER INITIAL IMPLANTATION BECAUSE SHE FELL ON HER HIP AND ONE OF THE SCREWS BROKE. THE SURGEON THOUGHT THAT IT HAPPENED BEFORE THE CUP HAD GOT ADEQUATE FIXATION AND BECAUSE OF HER AGE, DISLODGED. THE SURGEON BELIEVES HER AGE AND FRAGILITY WAS THE CAUSE OF HER FALL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Aseptic loosening
MAUDE report 23811738 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Medical device site infection; Necrosis; Scar Tissue
MAUDE report 23711726 ↗InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: Bursitis; Pain
MAUDE report 22893044 ↗InjuryAug 25, 2025Unintended Movement; Noise, Audible; Unintended Movement; Noise, Audible
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SNAPPING IN THE HIP APPROXIMATELY TWO YEARS POST-IMPLANTATION. IT WAS CONFIRMED THAT THE PATIENT HAD ILIOPSOAS TENDINITIS CAUSED BY IMPINGEMENT. PATIENT WAS REFERRED FOR AN INJECTION UNDER FLUOROSCOPY. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.
Patient problems: Joint Impingement; Pain; Tendinopathy
MAUDE report 22890474 ↗InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A LEFT HIP REVISION DUE TO LOOSENING OF THE ACETABULAR TRIFLANGE COMPONENT AND ACETABULAR BONE FRACTURE DUE TO UNKNOWN REASON. PATIENT IS EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Bone Fracture(s); Pain
MAUDE report 22826709 ↗InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A LEFT HIP REVISION DUE TO LOOSENING OF THE ACETABULAR TRIFLANGE COMPONENT AND ACETABULAR BONE FRACTURE DUE TO UNKNOWN REASON. PATIENT IS EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Bone Fracture(s); Pain
MAUDE report 22826706 ↗InjuryJul 24, 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 ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT IS LOOKING TO HAVE THE ACETABULAR COMPONENT REVISED DUE TO LOOSENING.
Patient problems: Aseptic loosening
MAUDE report 22587361 ↗InjuryJul 24, 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 ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT IS LOOKING TO HAVE THE ACETABULAR COMPONENT REVISED DUE TO LOOSENING.
Patient problems: Aseptic loosening
MAUDE report 22587358 ↗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 22564613 ↗InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Pain; Unequal Limb Length
MAUDE report 22436121 ↗InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY EIGHT YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO PAIN AND DIFFICULTIES WITH ADLS. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 22157354 ↗MalfunctionMay 8, 2025Fracture; Fracture
IT WAS REPORTED THAT THE COLLAR OF THE SCREW BROKE IN HALF WHILE THE SURGEON WAS INSERTING THE SCREW INTO THE CUP LEAVING THE REMAINING HEAD OF THE SCREW PROUD WITHIN THE SHELL. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21987713 ↗MalfunctionMay 8, 2025Fracture; Fracture
IT WAS REPORTED THAT THE COLLAR OF THE SCREW BROKE IN HALF WHILE THE SURGEON WAS INSERTING THE SCREW INTO THE CUP LEAVING THE REMAINING HEAD OF THE SCREW PROUD WITHIN THE SHELL. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21987698 ↗MalfunctionMar 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT WHEN OPENING THE STERILE BOX DURING SURGERY, A HAIR WAS FOUND. 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 21717882 ↗InjuryMar 26, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TRILOGY 6.5MM SCREW BROKE DURING SURGERY. THERE WAS NO DELAY IN SURGERY. THE BROKE DISTAL SCREW REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 21700436 ↗InjuryMar 5, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 YEAR AND 6 MONTHS POST IMPLANTATION DUE TO CUP MALPOSITIONING AND THE ACETABULAR SCREW BREAKING THROUGH THE CUP. THE ACETABULAR CUP WAS REMOVED AND REPLACED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21525945 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY. APPROXIMATELY 2 YEARS LATER THE PATIENT RECEIVED A CORTISONE INJECTION TO THE RIGHT HIP FOR BURSITIS AND REPORTED AS RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bursitis; Pain
MAUDE report 20846390 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY. APPROXIMATELY 2 YEARS LATER THE PATIENT RECEIVED A CORTISONE INJECTION TO THE RIGHT HIP FOR BURSITIS AND REPORTED AS RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bursitis; Pain
MAUDE report 20846319 ↗InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Bursitis; Pain; Unequal Limb Length
MAUDE report 20833325 ↗MalfunctionOct 10, 2024Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416462 ↗InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR UNKNOWN REASONS NEARLY TWO MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 20367898 ↗InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED 2 YEARS AND 2 MONTHS POST IMPLANTATION, THE PATIENT WAS GIVEN A CORTISONE INJECTION FOR LEFT HIP BURSITIS. THE BURSITIS WAS LIKELY RELATED TO THE INITIAL PROCEDURE. THERE ARE NO PLANS FOR THE PATIENT TO BE REVISED. ALL DEVICES REMAIN IMPLANTED.THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bursitis
MAUDE report 20205209 ↗InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED EIGHT (8) YEARS POST IMPLANTATION DUE TO PAIN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 19578745 ↗InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 19567533 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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