Endo-Model Standard Knee Prosthesis SystemRecalls & reported problems across all models
WALDEMAR LINK GmbH & Co. KG · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one Endo-Model Standard Knee Prosthesis System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 6
We found 15 models of Endo-Model Standard Knee Prosthesis System by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 19 adverse event reports in the FDA's MAUDE database, received between Mar 22, 2023 and Sep 24, 2026 — classified as 16 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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
Endo-Model Standard Knee Prosthesis System 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 6, 2026Open, Classified
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
Z-2934-2026 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 12, 2026Open, Classified
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Z-1523-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 12, 2026Open, Classified
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Z-1522-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 12, 2026Open, Classified
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Z-1521-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 12, 2026Open, Classified
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Z-1517-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 12, 2026Open, Classified
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Z-1512-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Endo-Model Standard Knee Prosthesis System problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth4
- Unstable3
- Detachment of Device or Device Component2
- Device Appears to Trigger Rejection2
- Fracture2
- Naturally Worn2
- Nonstandard Device2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions5
- Pain3
- Implant Pain2
- Ambulation or Postural Difficulties1
- Aseptic loosening1
- Hypersensitivity/Allergic reaction1
- Joint Laxity1
Endo-Model Standard Knee Prosthesis System models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Endo-Model Standard Knee Prosthesis System 15-0027/16Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Endo-Model Standard Knee Prosthesis System 15-0027/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall1 report
- Endo-Model Standard Knee Prosthesis System 15-8030/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Standard Knee Prosthesis System 15-0027/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Standard Knee Prosthesis System 15-0027/15Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Standard Knee Prosthesis System 15-2516/29Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer5 reports
- Endo-Model Standard Knee Prosthesis System 15-2975/12Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2 reports
- Endo-Model Standard Knee Prosthesis System 15-0027/14Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- Endo-Model Standard Knee Prosthesis System 15-9024/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Standard Knee Prosthesis System 15-9030/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Standard Knee Prosthesis System 15-8022/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Standard Knee Prosthesis System 15-8024/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Standard Knee Prosthesis System 15-8024/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Standard Knee Prosthesis System 15-2517/29Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Standard Knee Prosthesis System 16-2011/21Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Recent Endo-Model Standard Knee Prosthesis System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Nonstandard Device
Notified on 9/17/2026 in response to an email requesting to quarantine the product, that he opened 2 parts in a procedure on (b)(6)2026 and noticed that the parts were a different size other than the size called out on the label. There wasn't much delay in the procedure and no patient harm. The decision was made at the time to use a size 14 instead and that product was available to use and was the correct size. "[Customer]".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877889 ↗MalfunctionSep 23, 2026Nonstandard Device
The product inside the box was the incorrect size. "[Customer]".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865251 ↗InjuryAug 25, 2026Fracture
InjuryJun 4, 2026Loosening of Implant Not Related to Bone-Ingrowth
ASEPTIC LOOSENING OF LEFT KNEE PROTHESIS "[CUSTOMER]".
Patient problems: Aseptic loosening
MAUDE report 25388967 ↗InjuryMay 13, 2026Fracture; Naturally Worn
FRACTURED FEMORAL COMPONENT. \[CUSTOMER]"
Patient problems: Insufficient Information
MAUDE report 25157463 ↗InjurySep 25, 2025Unstable; Appropriate Device Problem Term/Code Not Available; Unstable; Appropriate Device Problem Term/Code Not Available
REPORTED TO LINKBIO, ON (B)(6) 2025, THAT THIS PATIENT WILL REQUIRE A REVISION OF THE EXISTING LINK DEVICE WITH A CUSTOM-MADE IMPLANT. DR. BELIEVES THE CURRENT IN-SITU LINK DEVICE CONTRIBUTED TO THE NEED FOR REVISION, AS THE PLASTIC IN THE TIBIAL COMPONENT IS COMPRESSIBLE AND IS CAUSING THE PATIENT PAIN. [CUSTOMER] THE REVISION HAS NOT BEEN PERFORMED YET.
Patient problems: Pain
MAUDE report 23140784 ↗InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DURING A TELEPHONE VISIT WITH THE PATIENT ON (B)(6) 2025, THE SURGEON RECOMMENDED THE PATIENT UNDERGO REVISION TKA FOR KNEE PAIN. DURING A PRIOR VISIT ON (B)(6) 2025, THE X-RAYS SHOWED WELL-FIXED TIBIAL AND FEMORAL COMPONENTS, BUT THE PHYSICIAN BELIEVES A POLYETHYLENE AUGMENT (IMPLANTED (B)(6) 2022) MAY BE CAUSING PAIN.
Patient problems: Implant Pain
MAUDE report 22904776 ↗InjuryJul 24, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth
BASED ON A REVIEW OF PATIENT STAGING STUDIES ON (B)(6) 2024, THE PHYSICIAN NOTED UPTAKE AROUND THE LEFT KNEE AND SUSPECTS THAT REVISION OF THE TIBIAL COMPONENTS IS NEEDED, POTENTIALLY RELATED TO THE TIBIAL UHMWPE AUGMENT. REVISION HAS NOT OCCURRED. THE PATIENT WILL SEEK ANOTHER OPINION. [(B)(6)].
Patient problems: Pain
MAUDE report 22584668 ↗InjuryJul 2, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth
MOBILIZATION KNEE PROSTHESES. [CUSTOMER].
Patient problems: Insufficient Information
MAUDE report 22381562 ↗InjuryJan 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IN A REQUEST FORM FROM DR. M FOR A COMPASSION USE REVISION, THE DOCTOR MENTIONED THAT HE SUSPECTED THAT THE POLY AUGMENTS IMPLANTED ON (B)(6) 2021 MAY BE LOOSE. RECEIVED THE POST-OP REPORT ON (B)(6) 2025 , STATING THAT THE TIBIAL COMPONENT SHOWED EVIDENCE OF LOOSENING. THE REVISION WAS COMPLETED ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 21232687 ↗InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT KNEE REVISION SURGERY (B)(6) 2021 FOR A PREVIOUSLY INFECTED KNEE (MANUFACTURER UNKNOWN) AND NICKEL ALLERGY. THIS TIBIAL AUGMENT WAS IMPLANTED AT THAT TIME WITH A LINK POREX KNEE SYSTEM. IT APPEARS THAT THE FEMORAL SIDE WAS LATER REVISED (CAUSE UNKNOWN) ON (B)(6) 2023. DR. NOW PLANS TO REVISE THIS PATIENT DUE TO RIGHT KNEE PAIN, WHICH HE SUSPECTS IS RELATED TO THE UHMWPE TIBIAL AUGMENT. [CUSTOMER]
Patient problems: Hypersensitivity/Allergic reaction; Pain; Unspecified Infection
MAUDE report 20187871 ↗InjurySep 10, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT UNDERWENT KNEE REVISION SURGERY (B)(6) 2021 FOR A PREVIOUSLY INFECTED KNEE (MANUFACTURER UNKNOWN) AND NICKEL ALLERGY. THIS TIBIAL AUGMENT WAS IMPLANTED AT THAT TIME WITH A LINK POREX KNEE SYSTEM. IT APPEARS THAT THE FEMORAL SIDE WAS LATER REVISED (CAUSE UNKNOWN) ON (B)(6) 2023. DR. NOW PLANS TO REVISE THIS PATIENT DUE TO RIGHT KNEE PAIN, WHICH HE SUSPECTS IS RELATED TO THE UHMWPE TIBIAL AUGMENT.
Patient problems: Implant Pain
MAUDE report 20181768 ↗InjuryAug 1, 2024Off-Label Use; Unstable; Detachment of Device or Device Component; Off-Label Use; Unstable; Detachment of Device or Device Component
IN (B)(6) 2024, A FEELING OF KNEE FAILURE WAS REPORTED. X-RAY DIAGNOSIS SHOWS UNSTABLE KNEE. [CUSTOMER].
Patient problems: Joint Laxity
MAUDE report 19882304 ↗InjuryApr 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT HAS HAD MULTIPLE REVISIONS. . THE SUBJECT DEVICES WERE IMPLANTED DURING REVISION KNEE ARTHROPLASTY ON (B)(6) 2024. SUBSEQUENTLY, ON (B)(6) 2024 THE PATIENT PRESENTED TO THE EMERGENCY DEPT. WITH INFECTED KNEE WOUND DEHISCENCE AND WAS TAKEN TO SURGERY FOR IRRIGATION AND DEBRIDEMENT DURING WHICH THE FEMORAL COMPONENT AND TIBIAL PLATEAU WERE REPLACED AS PART OF THE WASHOUT. NO INFORMATION ALLEGES IMPLANT PERFORMANCE ISSUES OR OBSERVED IMPLANT DAMAGE.
Patient problems: Medical device site infection
MAUDE report 19173638 ↗InjuryJan 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT PRESENTED WITH DIFFICULTY WALKING, COMBINED WITH CLICKING AND LOCKING IN THE RIGHT KNEE SUBSEQUENT TO A DEC 2022 TKA (REVISION). X-RAYS SHOWS SOME OFFSET OF FEMUR WITH RESPECT TO THE TIBIAL PLATEAU. BOTH THE FEMORAL AND TIBIAL COMPONENTS APPEAR SECURELY FIXED ON X-RAY. REVISION SURGERY IS SCHEDULED FOR 01/23/2024.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 18477841 ↗
Other WALDEMAR LINK GmbH & Co. KG products
- Unicondylar Sled Prosthesis48 models · 12 reports · 48 recalls
- Endo-Model Modular Knee Prosthesis System64 models · 57 reports · 12 recalls
- LinkSymphoKnee117 models · 79 reports · 11 recalls
- LINK Instrument14 models · 8 reports · 12 recalls
- Endo-Model SL Knee Prosthesis System25 models · 52 reports · 6 recalls
- LINK Embrace Shoulder System Line Extension2 models · 1 reports · 4 recalls
- SPII Model Lubinus174 models · 6 reports · 3 recalls
- Endo-Model Knee System - Instruments5 models · 6 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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