CPTRecalls & reported problems across all models
Zimmer, Inc. · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one CPT model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 103
- Deaths reported
- 0
- Injuries reported
- 99
- Recalls
- 1
We found 27 models of CPT by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 103 adverse event reports in the FDA's MAUDE database, received between Jan 28, 2020 and Jun 23, 2026 — classified as 99 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 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
Reports received per month, all models
CPT 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.
- Jul 2, 2024Open, Classified
Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
Z-2450-2024 · Root cause: Under Investigation by firm · names 25 of these models · Recall details · FDA record ↗
Most reported CPT problems
Device problems
- Adverse Event Without Identified Device or Use Problem82
- Loosening of Implant Not Related to Bone-Ingrowth11
- Fracture4
- Insufficient Device Problem Information2
- Migration2
- Difficult to Insert1
- Inadequacy of Device Shape and/or Size1
- Loss of or Failure to Bond1
Patient problems
- Bone Fracture(s)57
- Fall13
- Periprosthetic fracture13
- Insufficient Information10
- Failure of Implant7
- Pain6
- Unequal Limb Length5
- Aseptic loosening4
CPT models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CPT® 8114-01-10Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall24 reports
- CPT® 8114-01Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall11 reports
- CPT® 8114-02-10Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall11 reports
- CPT® 8114-03-10Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall11 reports
- CPT® 8114-00-10Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall10 reports
- CPT® 8114-02Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall9 reports
- CPT® 8114-02-30Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall6 reports
- CPT® 8114Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall4 reports
- CPT® 8114-02-18Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall3 reports
- CPT® 8114-03Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall2 reports
- CPT® 8114-04-10Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall2 reports
- CPT® 8114-03-18Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall1 report
- CPT® 8114-03-30Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall1 report
- CPT® 8114-04-20Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall1 report
- CPT® 8114-04-26Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall1 report
- CPT® 8114-04-30Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall1 report
- CPT® 8114-05-30Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall1 report
- CPT® 8114-50Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall1 report
- CPT® 8114-04Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall0 reports
- CPT® 8114-04-23Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall0 reports
- CPT® 8114-05Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall0 reports
- CPT® 8114-05-10Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall0 reports
- CPT® 8114-12-18Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall0 reports
- CPT® 8114-13-18Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall0 reports
- CPT® 8114-40Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall0 reports
- CPT® 8334-13ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- CPT® 32-8334-10-02ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent CPT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
No additional information available for the reported event.
Patient problems: Periprosthetic fracture
MAUDE report 25596022 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 1-MONTH POST IMPLANTATION DUE TO A SUSPECTED POST-OPERATIVE INFECTION. DURING THE PROCEDURE, THE SURGEON NOTED THAT THERE WAS A FRACTURE OF THE GREATER TROCHANTER WHICH WAS NOT EVIDENT ON X-RAY. MAY HAVE INDICATED A FALL OR MIGHT BE RELATED TO INFECTION. THE STEM REMAINS IMPLANTED, FEMORAL HEAD AND BIPOLAR COMPONENTS REVISED. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: Bone Fracture(s); Unspecified Infection
MAUDE report 24887115 ↗InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION DUE TO A PERIPROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 24314447 ↗InjuryJan 6, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT INITIALLY UNDERWENT HIP ARTHROPLASTY WITH IMPLANTATION OF ZIMMER BIOMET PRODUCTS. MORE THAN TWO (2) YEARS AFTER IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING. THE ENTIRE CONSTRUCT WAS REMOVED.
Patient problems: Aseptic loosening
MAUDE report 23977247 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 1-MONTH POST IMPLANTATION DUE TO A SUSPECTED POST OPERATIVE INFECTION. DURING THE PROCEDURE, THE SURGEON NOTED THAT THERE WAS A FRACTURE OF THE GREATER TROCHANTER WHICH WAS NOT EVIDENT ON X-RAY. MAY HAVE INDICATED A FALL OR MIGHT BE RELATED TO INFECTION. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: Bone Fracture(s); Unspecified Infection
MAUDE report 23977140 ↗InjuryDec 18, 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: Pain; Periprosthetic fracture
MAUDE report 23843122 ↗InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO A PERIPROSTHETIC FRACTURE. NO FURTHER DETAILS OR OUTCOMES PROVIDED. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 23789907 ↗InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 18 MONTHS POST-IMPLANTATION DUE TO A PERIPROSTHETIC FRACTURE. PRIOR TO THE REVISION, THE PATIENT SUSTAINED A FALL. DURING THE REVISION PROCEDURE, THE FEMORAL STEM WAS EXPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Fall; Periprosthetic fracture
MAUDE report 23594717 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF COMPETITOR PRODUCTS DUE TO A MSSA INFECTION. DURING THE PROCEDURE AN ANTEROLATERAL CORTICAL BREACH OCCURRED WHILE ATTEMPTING TO REMOVE THE COMPETITOR¿S DISTAL CEMENT MANTLE, CREATING A PROPAGATED FRACTURE. A ZIMMER BIOMET TOTAL HIP ARTHROPLASTY WAS IMPLANTED, AND THE PATIENT WAS DISCHARGED ON 25 PERCENT TOUCH WEIGHT BEARING RESTRICTIONS AND THREE MONTHS OF ANTIBIOTIC THERAPY. APPROXIMATELY ONE MONTH LATER, WHILE SWINGING THE PATIENT¿S LEGS INTO BED, FELT A CRACK AND DEVELOPED PAIN. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION WHERE ALL PRODUCTS WERE REVISED, AND CERCLAGE CABLES WERE IMPLANTED TO SECURE THE FRACTURE SITE. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain; Periprosthetic fracture
MAUDE report 23553489 ↗InjuryNov 10, 2025Loosening 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: Aseptic loosening
MAUDE report 23509972 ↗InjuryOct 16, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Aseptic loosening
MAUDE report 23309527 ↗InjurySep 8, 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 ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A FRACTURE. THE STEM WAS REVISED AND CABLES WERE IMPLANTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 22991166 ↗MalfunctionSep 3, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL EVENT INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22954590 ↗InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO YEARS POST-IMPLANTATION AFTER THE PATIENT FELL, RESULTING IN A PERIPROSTHETIC FRACTURE. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: Fall; Periprosthetic fracture
MAUDE report 22859790 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- Affixus18 models · 1 reports · 17 recalls
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 recalls
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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