IdentityRecalls & reported problems across all models
Zimmer, Inc. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Identity model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls
- 1
We found 20 models of Identity by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Sep 11, 2023 and Sep 22, 2026 — classified as 31 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
Identity 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.
- Dec 7, 2022Open, Classified
Two planers were found to be unusable during sawbones shoulder training.
Z-1098-2023 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗
Most reported Identity problems
Device problems
- Adverse Event Without Identified Device or Use Problem29
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated1
- Noise, Audible1
- Positioning Failure1
Patient problems
- Hematoma12
- Fluid Discharge8
- Pulmonary Embolism6
- Erythema4
- Impaired Healing4
- Swelling/ Edema4
- Thrombosis/Thrombus4
- Bone Fracture(s)3
Identity models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Identity™ SBHA4035REAMER1 recall0 reports
- Identity™ SBHA4040REAMER1 recall0 reports
- Identity™ SBHA4045REAMER1 recall0 reports
- Identity™ SBHA4050REAMER1 recall0 reports
- Identity™ SBHA4055REAMER1 recall0 reports
- Identity™ SAHAF135PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED5 reports
- Identity™ SAHHA001shoulder prosthesis, reverse configuration5 reports
- Identity™ SAHTNEM6PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Identity™ SAHH4817PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED3 reports
- Identity™ SAHS1108PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED3 reports
- Identity™ SAHTST00shoulder prosthesis, reverse configuration3 reports
- Identity™ SAHH5118PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- Identity™ SAHS1107PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Identity™ SAHS1109PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Identity™ SAHS1110PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
- Identity™ SAHS1111PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Identity™ SAHS1112PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- Identity™ SAHS1116shoulder prosthesis, reverse configuration1 report
- Identity™ SAHS1208PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Identity™ SAHS1212PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
Recent Identity adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported a postoperative humeral shaft fracture was identified following an initial procedure involving a humeral stem. The fracture was discovered during a postoperative follow-up examination. The surgeon noted an unusual sensation during provisional reduction in the initial surgery and commented that a crack may have initiated at that time. The patient was planned to undergo fixation with a plate, contingent on the absence of stem loosening. No further information has been provided.
Patient problems: Periprosthetic fracture
MAUDE report 50854738 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION FROM AN ANATOMIC CONSTRUCT TO A REVERSE CONSTRUCT DUE TO A GREATER TUBEROSITY FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Loss of fracture reduction
MAUDE report 25135919 ↗InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT HAD AN INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY 15 DAYS POST-IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Arthropathy; Insufficient Information
MAUDE report 22874509 ↗InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT HAD AN INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY 15 DAYS POST-IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Arthropathy; Insufficient Information
MAUDE report 22874500 ↗MalfunctionJul 10, 2025Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469042 ↗InjuryApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 21876846 ↗InjuryApr 3, 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 SHOULDER ARTHROPLASTY APPROXIMATELY TWO (2) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION APPROXIMATELY ONE (1) MONTH AGO.
Patient problems: Unspecified Infection
MAUDE report 21764744 ↗InjuryMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY ONE (1) YEAR AND TWO (2) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE DISASSOCIATION OF THE IMPLANTS.
Patient problems: Failure of Implant
MAUDE report 21605436 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT DEVELOPED A DVT/PE APPROXIMATELY 2 MONTHS POST IMPLANTATION OF A LEFT SHOULDER ARTHOPLASTY. THE PATIENT WAS HOSPITALIZED AND PLACED ON MEDICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 20138286 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT DEVELOPED A DVT/PE APPROXIMATELY 2 MONTHS POST IMPLANTATION OF A LEFT SHOULDER ARTHROPLASTY. THE PATIENT WAS HOSPITALIZED AND PLACED ON MEDICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 20138264 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT DEVELOPED A DVT/PE APPROXIMATELY 2 MONTHS POST IMPLANTATION OF A LEFT SHOULDER ARTHROPLASTY. THE PATIENT WAS HOSPITALIZED AND PLACED ON MEDICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 20138260 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT DEVELOPED A DVT/PE APPROXIMATELY 2 MONTHS POST IMPLANTATION OF A LEFT SHOULDER ARTHOPLASTY. THE PATIENT WAS HOSPITALIZED AND PLACED ON MEDICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 20138259 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT ANATOMICAL TOTAL SHOULDER ARTHROPLASTY. ONE MONTH POST-OP, THE PATIENT DEVELOPED SUBCUTANEOUS SWELLING REDNESS AT THE PROXIMAL INCISION, AND A HEMATOMA. THE PATIENT WAS PLACED ON CLINDAMYCIN AND DOXYCYCLINE AND WAS RESOLVED WITHOUT FURTHER COMPLICATIONS. ALL IMPLANTS REMAIN IN PLACE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Erythema; Hematoma; Swelling/ Edema
MAUDE report 20137131 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT ANATOMICAL TOTAL SHOULDER ARTHROPLASTY. ONE MONTH POST-OP, THE PATIENT DEVELOPED SUBCUTANEOUS SWELLING REDNESS AT THE PROXIMAL INCISION, AND A HEMATOMA. THE PATIENT WAS PLACED ON CLINDAMYCIN AND DOXYCYCLINE AND WAS RESOLVED WITHOUT FURTHER COMPLICATIONS. ALL IMPLANTS REMAIN IN PLACE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Erythema; Hematoma; Swelling/ Edema
MAUDE report 20137101 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT ANATOMICAL TOTAL SHOULDER ARTHROPLASTY. ONE MONTH POST-OP, THE PATIENT DEVELOPED SUBCUTANEOUS SWELLING REDNESS AT THE PROXIMAL INCISION, AND A HEMATOMA. THE PATIENT WAS PLACED ON CLINDAMYCIN AND DOXYCYCLINE AND WAS RESOLVED WITHOUT FURTHER COMPLICATIONS. ALL IMPLANTS REMAIN IN PLACE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Erythema; Hematoma; Swelling/ Edema
MAUDE report 20136931 ↗
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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