NexGenRecalls & reported problems across all models
Zimmer, Inc. · 198 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one NexGen model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 842
- Deaths reported
- 0
- Injuries reported
- 600
- Recalls
- 4
We found 198 models of NexGen by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 842 adverse event reports in the FDA's MAUDE database, received between Sep 10, 2019 and Sep 30, 2026 — classified as 600 injuries, 242 malfunctions.
The most frequently reported specific device problem is “Fracture” (207 reports).
4 FDA recall records 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
NexGen 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.
- Mar 28, 2024Open, Classified
Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
Z-1608-2024 · Root cause: Process change control · names 4 of these models · Recall details · FDA record ↗
- May 19, 2023Terminated
Device outer packaging was incorrectly labeled.
Z-2092-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 31, 2018Terminated
Screw is missing from the package
Z-0630-2019 · Root cause: Process control · Recall details · FDA record ↗
- Apr 28, 2017Terminated
Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.
Z-2115-2017 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported NexGen problems
Device problems
- Adverse Event Without Identified Device or Use Problem280
- Fracture207
- Loosening of Implant Not Related to Bone-Ingrowth198
- Insufficient Device Problem Information34
- Migration31
- Difficult to Insert23
- Mechanical Jam23
- Detachment of Device or Device Component20
Patient problems
- Pain324
- No Clinical Signs, Symptoms or Conditions217
- Failure of Implant179
- Swelling/ Edema110
- Ambulation or Postural Difficulties80
- Aseptic loosening63
- Insufficient Information63
- Loss of Range of Motion55
NexGen models
198 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- NexGen® 5980-47-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall13 reports
- NexGen® 5988-20-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall3 reports
- NexGen® 5990-35-23PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall1 report
- NexGen® 5952-15-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- NexGen® 5952-15-02PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- NexGen® 5952-15-05PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- NexGen® 5952-15-06PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- NexGen® 5988-20-17PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- NexGen® 00-5901-020-00ORTHOPEDIC MANUAL SURGICAL INSTRUMENT36 reports
- NexGen® 5986-37-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER32 reports
- NexGen® 5986-37-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER32 reports
- NexGen® 00-5901-021-00EXTRACTOR28 reports
- NexGen® 00-5901-032-00ORTHOPEDIC MANUAL SURGICAL INSTRUMENT24 reports
- NexGen® 5980-37-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER23 reports
- NexGen® 5986-47-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER21 reports
- NexGen® 5972-65-32PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER20 reports
- NexGen® 5980-37-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER18 reports
- NexGen® 00-5901-033-00ORTHOPEDIC MANUAL SURGICAL INSTRUMENT17 reports
- NexGen® 5980-47-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- NexGen® 5988-12-15PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- NexGen® 5880-16-02PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER16 reports
- NexGen® 5986-47-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- NexGen® 5881-26ORTHOPEDIC MANUAL SURGICAL INSTRUMENT14 reports
- NexGen® 5972-65-35PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- NexGen® 5987-71SCREWDRIVER14 reports
- NexGen® 5972-65-35PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- NexGen® 5980-27-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- NexGen® 5972-65-32PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- NexGen® 5990-36-10PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- NexGen® 5880-14-02PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- NexGen® 5880-15-01PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- NexGen® 5951-90IMPACTOR10 reports
- NexGen® 5986-57-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- NexGen® 5972-65-29PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- NexGen® 5880-14-01PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- NexGen® 5880-16-01PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- NexGen® 5880-40-12PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- NexGen® 5880-60-12PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- NexGen® 5972-65-29PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- NexGen® 5880-04PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- NexGen® 5880-50-12PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- NexGen® 5987-89SCREWDRIVER7 reports
- NexGen® 5997-73ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- NexGen® 5880-05PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- NexGen® 5880-15-02PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- NexGen® 5880-40-14PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- NexGen® 5980-57-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® 5988-03PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® 5988-05PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® 5988-10-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® 5988-10-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® 5988-10-13PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® 5988-10-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® 5988-20-11PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® 5990-36-20PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- NexGen® 90-5970-30-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® 5880-03PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- NexGen® 5880-50-14PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- NexGen® 5880-60-17PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- NexGen® 5970-45-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- NexGen® 5988-10-15PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- NexGen® 5990-36-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- NexGen® 90-5970-40-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- NexGen® 5880-02-02PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- NexGen® 5880-03-02PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- NexGen® 5880-06PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- NexGen® 5880-13-01PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- NexGen® 5880-20-12PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- NexGen® 5880-30-12PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- NexGen® 5880-60-14PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- NexGen® 5950-15-06PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® 5980-90PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® 5986-57-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® 5988-04PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® 5990-34-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® 90-5970-30-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® 90-5970-50-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® 90-5970-50-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® 5990-34-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® 5972-65-26PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® 5972-65-38PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- NexGen® 00-5850-075-16PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- NexGen® 5880-30-14PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- NexGen® 5880-40-20PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- NexGen® 5880-90-13PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- NexGen® 00-5901-034-00ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- NexGen® 5950-15-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® 5950-16-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® 5950-17-06PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® 5960-99PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® 5970-45-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® 5970-55-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® 5971-40-12TEMPLATE2 reports
- NexGen® 5976-30-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® 5980-57-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® 5981-47-01TEMPLATE2 reports
- NexGen® 5988-04-26PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- NexGen® 5988-10-11PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® 5988-11-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- NexGen® 5988-11-17PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
Recent NexGen adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that the patient underwent an initial left knee surgery. Approximately 4.6 years post-implantation a revision due to tibial loosening and a broken cement mantle. Attempts have been made and no further information has been provided.
Patient problems: Aseptic loosening
MAUDE report 50948295 ↗InjurySep 30, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that the patient underwent an initial left knee surgery. Approximately 4.6 years post-implantation a revision due to tibial loosening and a broken cement mantle. Attempts have been made and no further information has been provided.
Patient problems: Aseptic loosening
MAUDE report 50948271 ↗MalfunctionSep 29, 2026Manufacturing, Packaging or Shipping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934181 ↗InjurySep 28, 2026Fracture; Damaged Thread
It was reported that a patient was revised approximately three years and nine months post implantation due to pain caused by implant fracture. The patient experienced pain and x-rays showed metallic pieces inside. At explant, the femoral condyle hinge was found fractured in half. The rotational bolt had engaged the proximal threaded portion that articulates in the hinge. There is no additional information available.
Patient problems: Pain
MAUDE report 50915012 ↗InjurySep 28, 2026Fracture
Patient problems: Pain
MAUDE report 50914990 ↗InjurySep 24, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that a patient had a TKA on an unknown date. Subsequently, a knee revision was being considered due to chronic infection and loosening. Attempts have been made and no further information has been provided.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50883730 ↗InjurySep 22, 2026Insufficient Device Problem Information
It was reported that the patient is experiencing unknown complications approximately nine (9) years following left knee arthroplasty.No additional information is available.
Patient problems: Insufficient Information
MAUDE report 50856787 ↗InjurySep 22, 2026Insufficient Device Problem Information
It was reported that the patient is experiencing unknown complications approximately nine (9) years following left knee arthroplasty.No additional information is available.
Patient problems: Insufficient Information
MAUDE report 50856577 ↗MalfunctionSep 17, 2026Fracture
It was reported that the spike arm fractured during an initial total knee arthroplasty. There was no patient impact and no adverse events have been reported as a result of the malfunction. All available information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805721 ↗MalfunctionSep 1, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551978 ↗InjuryAug 17, 2026Fracture
It was reported that a patient underwent a left total knee arthroplasty. Approximately two (2) years and two (2) months post-implantation, the patient sustained a torsional injury to the implanted joint, thus resulting in instability. Radiographic evaluation revealed displacement of the hinge mechanism indicating possible implant failure of the hinge assembly. Subsequently, the patient underwent revision surgery in which the femoral hinge post was found to be fractured. The affected components were replaced without reported complication. Due diligence is in progress for this event; to date all available information has been provided.
Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Joint effusion; Swelling/ Edema
MAUDE report 50284027 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
It was reported patient underwent a revision procedure approximately 6 years post implantation due to unknown reasons. Attempts to obtain additional information have been made; however, no more is available.
Patient problems: Insufficient Information
MAUDE report 50236866 ↗InjuryAug 13, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported patient is experiencing loosening approximately five years post implantation. No further information is available.
Patient problems: Aseptic loosening
MAUDE report 50234445 ↗InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent an initial TKA. Subsequently, about 9 years postop, they had a revision due to instability. The surgical technique was utilized. There was no surgical delay. Attempts have been made and no additional information has been provided.
Patient problems: Joint Laxity
MAUDE report 50227154 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient underwent a right total knee arthroplasty and was subsequently revised approximately 1 year and 6 months post-implantation due to instability and mechanical loosening. Subsequently, 3 months after the revision, the patient began experiencing pain, swelling, stiffness, fever in the knee, and limitations in normal activities following the procedure. The devices remain implanted. Attempts have been made and no further information has been provided.
Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema
MAUDE report 50143824 ↗
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
- 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
- Comprehensive18 models · 103 reports · 3 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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