Trabecular MetalRecalls & reported problems across all models
Zimmer, Inc. · 74 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 243
- Deaths reported
- 0
- Injuries reported
- 194
- Recalls
- 0
We found 74 models of Trabecular Metal by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 243 adverse event reports in the FDA's MAUDE database, received between Nov 1, 2019 and Jul 1, 2026 — classified as 194 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (51 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. 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
Most reported Trabecular Metal problems
Device problems
- Adverse Event Without Identified Device or Use Problem82
- Device Dislodged or Dislocated51
- Detachment of Device or Device Component36
- Difficult to Insert20
- Loosening of Implant Not Related to Bone-Ingrowth18
- Fracture16
- Unstable10
- Migration7
Patient problems
- Joint Dislocation59
- Pain56
- No Clinical Signs, Symptoms or Conditions48
- Failure of Implant37
- Insufficient Information21
- Bone Fracture(s)13
- Loss of Range of Motion10
- Bursitis7
Trabecular Metal models
74 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Trabecular Metal® 00-4349-036-11PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED17 reports
- Trabecular Metal® 00-4349-012-13PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED14 reports
- Trabecular Metal® 00-4349-025-02PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED10 reports
- Trabecular Metal® 00-4349-036-03PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED9 reports
- Trabecular Metal® 00-4349-014-13PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- Trabecular Metal® 00-7864-013-20PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED7 reports
- Trabecular Metal® 00-4349-015-00PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED7 reports
- Trabecular Metal® 00-4349-036-00PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- Trabecular Metal® 00-4349-066-06PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- Trabecular Metal® 00-4349-036-06PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Trabecular Metal® 00-4349-040-11PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Trabecular Metal® 6202-54-22Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- Trabecular Metal® 00-4309-029-00PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- Trabecular Metal® 00-4349-065-06PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED5 reports
- Trabecular Metal® 47-4309-025-01PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- Trabecular Metal® 6202-52-20PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Trabecular Metal® 6202-58-20Prosthesis, hip, constrained, cemented or uncemented, metal/polymer4 reports
- Trabecular Metal® 00-7864-013-00PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Trabecular Metal® 00-7864-014-20PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Trabecular Metal™ 00-4309-041-00PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Trabecular Metal® 00-4349-039-12PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED4 reports
- Trabecular Metal® 00-4349-040-03PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED4 reports
- Trabecular Metal® 00-4349-065-03PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Trabecular Metal® 00-4349-036-00PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED4 reports
- Trabecular Metal® 00-4349-040-06PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED4 reports
- Trabecular Metal® 6202-50-20Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- Trabecular Metal® 6202-52-22Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- Trabecular Metal® 6202-56-20PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Trabecular Metal® 00-7864-011-00PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Trabecular Metal® 00-5852-040-35PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Trabecular Metal® 00-4349-010-13PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED3 reports
- Trabecular Metal® 00-4349-040-06PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Trabecular Metal® 00-4500-044-00PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Trabecular Metal® 00-4501-040-05PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Trabecular Metal® 00-4349-036-03PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Trabecular Metal® 6202-50-22PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Trabecular Metal™ 00-7124-056-48PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Trabecular Metal® 00-7864-012-00PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Trabecular Metal® 00-5850-032-46PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Trabecular Metal® 00-5852-040-25PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Trabecular Metal® 00-5852-040-30PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Trabecular Metal® 00-4349-008-13PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Trabecular Metal® 00-4349-016-13PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- Trabecular Metal® 00-4349-030-02PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Trabecular Metal® 00-4349-038-11PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Trabecular Metal® 00-4349-039-09PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Trabecular Metal® 00-4349-065-00PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Trabecular Metal® 00-4350-013-13PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Trabecular Metal® 00-4501-076-00PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Trabecular Metal® 00-4349-036-06PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Trabecular Metal® 00-4349-066-06PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Trabecular Metal® 6202-60-20PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Trabecular Metal® 6202-62-20Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- Trabecular Metal® 6202-62-22PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Trabecular Metal® 00-7864-012-20PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Trabecular Metal® 00-7864-014-00PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Trabecular Metal® 00-7864-015-20PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Trabecular Metal® 00-7864-018-00PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Trabecular Metal® 00-5850-001-10PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Trabecular Metal® 00-5850-003-10PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Trabecular Metal® 00-5852-041-35PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Trabecular Metal® 00-4309-028-00PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- Trabecular Metal® 00-4309-039-00PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Trabecular Metal® 00-4309-041-01PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Trabecular Metal® 00-4309-042-02PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Trabecular Metal® 4342-110-13PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- Trabecular Metal® 00-4349-018-13PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Trabecular Metal® 00-4349-040-00PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- Trabecular Metal® 00-4349-066-03PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Trabecular Metal® 00-4500-024-00PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Trabecular Metal® 00-4500-043-00PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Trabecular Metal® 00-4349-040-00PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Trabecular Metal® 00-4349-065-06PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Trabecular Metal® 00-4349-066-03PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
Recent Trabecular Metal adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT-MATCHED IMPLANT (PMI) GROUP THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY DUE TO PAIN. IT APPEARS FROM IMAGING THAT THE PATIENT HAS MODERATE SCAPULAR NOTCHING. THE PATIENT HAS NOT BEEN SCHEDULED FOR A REVISION, AND DUE TO HER PAST MEDICAL HISTORY MAY NOT GET CLEARED FOR ANOTHER PROCEDURE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Notching; Pain
MAUDE report 25678909 ↗InjuryJun 11, 2026Fracture
IT WAS REPORTED THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY TO TREAT A PROXIMAL HUMERUS FRACTURE, AFTER WHICH METAL FRAGMENTS WERE DETECTED ON FOLLOW-UP IMAGING AND SURGERY TO REMOVE THEM WAS SCHEDULED. POSTOPERATIVE RADIOGRAPHS IMMEDIATELY AFTER THE PROCEDURE WERE REPORTED AS NORMAL. DURING A ROUTINE FOLLOW-UP APPROXIMATELY ONE MONTH POST-IMPLANTATION, RADIOGRAPHS SHOWED METAL FRAGMENTS, AND A PROCEDURE TO REMOVE THE RESIDUAL FRAGMENTS WAS SCHEDULED. THE PATIENT DEVELOPED AN INFECTION AT THE SITE WHERE THE FRAGMENT REMAINS. THE PATIENT WAS SCHEDULED FOR SURGICAL REMOVAL OF THE FRAGMENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient; Post Operative Wound Infection
MAUDE report 25472065 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD A SHOULDER COMPONENT EXPLANTED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25248483 ↗MalfunctionMay 21, 2026Fracture
IT WAS REPORTED THAT THE TIP OF THE BASEPLATE CENTERING PIN BROKE OFF DURING SURGERY. IT WAS NOT NOTICED DURING THE PROCEDURE, BUT DISCOVERED IN A FOLLOWUP X RAY THAT A FRAGMENT HAD FRACTURED AND BEEN RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 25246781 ↗MalfunctionMar 3, 2026Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE PIN OF THE IMPACTOR FRACTURED DURING SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497540 ↗InjuryFeb 16, 2026Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation; Pain
MAUDE report 24343974 ↗InjuryJan 27, 2026Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening
MAUDE report 24188481 ↗InjuryJan 8, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: Aseptic loosening; Damage to Ligament(s); Joint Dislocation
MAUDE report 24011627 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT-MATCHED IMPLANT (PMI) GROUP THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT DUE TO PAIN WITH ONSET ON AN UNKNOWN DAY, WITH INCONSISTENT RETURNS TO THE PHYSICIAN. IMAGING APPARENTLY SHOW THAT THE PATIENT IS EXPERIENCING SCAPULAR NOTCHING. THE PATIENT HAS NOT BEEN SCHEDULED FOR A REVISION, AND DUE TO HER PAST MEDICAL HISTORY MAY NOT GET CLEARED FOR ANOTHER PROCEDURE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Notching; Insufficient Information; Pain
MAUDE report 23975104 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT-MATCHED IMPLANT (PMI) GROUP THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Notching; Insufficient Information; Pain
MAUDE report 23975074 ↗InjuryJan 6, 2026No Apparent Adverse Event
IT WAS REPORTED BY THE PATIENT-MATCHED IMPLANT (PMI) GROUP THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Notching; Insufficient Information; Pain
MAUDE report 23975013 ↗MalfunctionDec 22, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23866044 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE TAPER ADAPTER TRIAL BROKE DURING THE CASE. NO BROKEN PIECES WERE RETAINED AND NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846417 ↗MalfunctionDec 18, 2025Difficult to Insert; Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846211 ↗InjuryDec 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT A REVERSE SHOULDER REVISION PROCEDURE APPROXIMATELY 5 MONTHS POST-IMPLANTATION DUE TO COMPONENT DILSOCATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 23693781 ↗
Other Zimmer, Inc. products
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- 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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