Endo-Model Modular Knee Prosthesis SystemRecalls & reported problems across all models
WALDEMAR LINK GmbH & Co. KG · 64 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
12 open recalls name at least one Endo-Model Modular Knee Prosthesis System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls
- 12
We found 64 models of Endo-Model Modular Knee Prosthesis System by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Sep 23, 2022 and Aug 24, 2026 — classified as 44 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 reports).
12 FDA recall records name at least one of these models by its device identifier, 12 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 Modular 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.
- 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-1520-2026 · 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-1519-2026 · 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-1518-2026 · 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-1516-2026 · 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-1515-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 22, 2024Open, Classified
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Z-2410-2024 · Root cause: Process design · names 43 of these models · Recall details · FDA record ↗
- May 24, 2022Open, Classified
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Z-1378-2022 · Root cause: Nonconforming Material/Component · names 6 of these models · Recall details · FDA record ↗
- May 24, 2022Open, Classified
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Z-1377-2022 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗
- Mar 18, 2021Open, Classified
The firm discovered through customer complaints that device segments may not meet specifications.
Z-2049-2023 · Root cause: Device Design · Recall details · FDA record ↗
- Mar 18, 2021Open, Classified
The firm discovered through customer complaints that device segments may not meet specifications.
Z-2048-2023 · Root cause: Device Design · Recall details · FDA record ↗
- Mar 18, 2021Open, Classified
The firm discovered through customer complaints that device segments may not meet specifications.
Z-2047-2023 · Root cause: Device Design · Recall details · FDA record ↗
- Mar 18, 2021Open, Classified
The firm discovered through customer complaints that device segments may not meet specifications.
Z-2046-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Endo-Model Modular Knee Prosthesis System problems
Device problems
- Detachment of Device or Device Component15
- Loosening of Implant Not Related to Bone-Ingrowth15
- Fracture6
- Separation Failure6
- Adverse Event Without Identified Device or Use Problem4
- Naturally Worn4
- Off-Label Use3
- Positioning Problem3
Patient problems
- Failure of Implant18
- Insufficient Information13
- No Clinical Signs, Symptoms or Conditions13
- Joint Laxity9
- Unspecified Infection7
- Hypersensitivity/Allergic reaction6
- Implant Pain5
- Pain4
Endo-Model Modular Knee Prosthesis System models
64 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Endo-Model Modular Knee Prosthesis System 15-3816/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3817/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls5 reports
- Endo-Model Modular Knee Prosthesis System 15-2814/02Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls3 reports
- Endo-Model Modular Knee Prosthesis System 15-3818/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Endo-Model Modular Knee Prosthesis System 15-2814/03Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Endo-Model Modular Knee Prosthesis System 15-3815/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3817/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-2814/04Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-2835/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-2836/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/09Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/15Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3818/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall1 report
- Endo-Model Modular Knee Prosthesis System 15-2816/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall1 report
- Endo-Model Modular Knee Prosthesis System 15-2836/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall1 report
- Endo-Model Modular Knee Prosthesis System 15-2834/03Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall1 report
- Endo-Model Modular Knee Prosthesis System 15-2834/04Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall1 report
- Endo-Model Modular Knee Prosthesis System 15-2979/01Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall1 report
- Endo-Model Modular Knee Prosthesis System 15-2979/02Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall1 report
- Endo-Model Modular Knee Prosthesis System 15-3815/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2815/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2815/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2816/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2817/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2817/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2818/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2818/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2814/01Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2835/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2837/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2837/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2838/11Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2834/01Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2834/02Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2973/05Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-2973/06Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/05Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/07Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/13Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/25Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/27Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/29Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/31Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/33Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/35Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/10Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer4 reports
- Endo-Model Modular Knee Prosthesis System 15-2964/02Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Endo-Model Modular Knee Prosthesis System 15-2964/03Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Endo-Model Modular Knee Prosthesis System 15-2951/25Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/06Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/08Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- Endo-Model Modular Knee Prosthesis System 15-8521/26Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- Endo-Model Modular Knee Prosthesis System 15-2811/12Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Modular Knee Prosthesis System 15-2950/04Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Modular Knee Prosthesis System 15-2951/21Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Modular Knee Prosthesis System 15-8521/14Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Modular Knee Prosthesis System 15-8521/30Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Modular Knee Prosthesis System 15-8521/32Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Modular Knee Prosthesis System 15-8521/34Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Modular Knee Prosthesis System 15-8521/36Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Modular Knee Prosthesis System 15-3950/05Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model Modular Knee Prosthesis System 15-3950/06Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
Recent Endo-Model Modular 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.
InjuryAug 24, 2026Misassembly by Users
The plateau fixation screw was not fully tightened; another surgery was necessary to tighten the screw further. "[customer]".
Patient problems: Insufficient Information
MAUDE report 50402534 ↗MalfunctionMar 16, 2026Separation Failure
REPORTED THAT IN A PROCEDURE, THE BLIND SCREW ON THE COMPONENT COULD NOT BE BACKED OUT. AN ADDITIONAL COMPONENT WAS OPENED AND THE TIBIAL COMPONENT FROM THAT IMPLANT WAS INSTEAD USED IN THE PROCEDURE. ONLY A DELAY OF APPROXIMATELY 5 MINUTES WAS REPORTED. NOTE: THE REPRESENTATIVE DID ENSURE THE SURGEON UNDERSTOOD THAT THE ALTERNATE CEMENTING TECHNIQUE SHOULD BE USED PER THE FIELD NOTICE ASSOCIATED WITH THE BLIND SCREW REMOVAL ISSUES, HOWEVER THE SURGEON DID NOT AGREE WITH THIS APPROACH AND PREFERRED TO OPEN A NEW IMPLANT. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604051 ↗InjuryFeb 26, 2026Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth
FRACTURE OF THE CONE [CUSTOMER].
Patient problems: Metal Related Pathology; Unspecified Infection
MAUDE report 24453932 ↗MalfunctionNov 14, 2025Nonstandard Device; Wrong Label; Nonstandard Device; Wrong Label
WRONG ARTICLE IN PACKAGING [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23551683 ↗InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
THE LINK ENDO-MODEL-M KNEE SYSTEM WAS IMPLANTED ON (B)(6) 2022. THE SURGEON SUSPECTS LOOSENING OF THE CEMENTED FEMORAL STEM AND PLANS REVISION WITH CEMENTLESS STEMS. [CUSTOMER].
Patient problems: Insufficient Information; Pain
MAUDE report 22584667 ↗InjuryJul 9, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE PATIENT HAD 2ND LEFT KNEE REVISION ON (B)(6) 2024, DURING WHICH A LINK HINGE KNEE WAS IMPLANTED. THE PATIENT EXPERIENCED PERSISTENT SWELLING AND EVENTUALLY ALSO INCREASED PAIN AND DECREASED ROM. AN INFECTION WORKUP WAS POSITIVE FOR STAPHYLOCOCCUS EPIDERMIS. REVISION SURGERY OCCURRED (B)(6) 2024 AND AN ANTIBIOTIC SPACER WAS PLACED. ACCORDING TO THE SURGEON, THE INFECTION WAS NOT DEVICE RELATED: THE PATIENT HAD A HISTORY OF MULTIPLE SURGERIES IN THE PAST AND VERY LIKELY HAD A HIDDEN INFECTION WITH STAPH EPIDERMIS THAT LED ULTIMATELY TO THE PROSTHETIC JOINT INFECTION, CAUSING FAILURE OF THE LINK IMPLANT.
Patient problems: Implant Pain; Medical device site infection
MAUDE report 22458174 ↗MalfunctionMay 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
REPRESENTATIVE (B)(6) REPORTED THAT IN 2 CASES FOR REVISIONS TO CONDYLAR REPLACEMENT COMPONENTS, ONE OF THE CONDYLAR CAPS WAS FOUND FLOATING IN THE JOINT SPACE UPON OPENING THE KNEE CAPSULE. THE CASE WAS A REVISION OF THE KNEE FOR INFECTION WHERE THE SURGEON WAS EITHER REPLACING OR REMOVING PARTS AND WASHING OUT THE KNEE. THE CAP WAS NOT REMOVED BY THE SURGEON BUT INSTEAD HAD COME DISLODGED PRIOR TO THE SURGERY. IN THIS CASE, THE FEMORAL COMPONENT REMAINED IMPLANTED WITHOUT THE CAP AND ONLY THE POLY TIBIAL PLATEAU WAS SWAPPED. NO DELAY IN THE PROCEDURE. [CUSTOMER].
Patient problems: Medical device site infection; Unspecified Infection
MAUDE report 22034673 ↗MalfunctionMay 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
REPRESENTATIVE (B)(6) REPORTED THAT IN 2 CASES FOR REVISIONS TO CONDYLAR REPLACEMENT COMPONENTS, ONE OF THE CONDYLAR CAPS WAS FOUND FLOATING IN THE JOINT SPACE UPON OPENING THE KNEE CAPSULE. THE CASE WAS A REVISION OF THE KNEE FOR INFECTION WHERE THE SURGEON WAS EITHER REPLACING OR REMOVING PARTS AND WASHING OUT THE KNEE. THE CAP WAS NOT REMOVED BY THE SURGEON BUT INSTEAD HAD COME DISLODGED PRIOR TO THE SURGERY. IN THIS CASE, THE ENTIRE IMPLANT WAS REMOVED AND REPLACED WITH A FUSION NAIL. THERE WAS NO DELAY IN THE PROCEDURE. [CUSTOMER].
Patient problems: Unspecified Infection
MAUDE report 22034672 ↗InjuryMay 1, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
REPORTED FROM A CASE OF A REVISION TO A CONDYLAR REPLACEMENT COMPONENT, ONE OF THE CONDYLAR CAPS WAS FOUND FLOATING IN THE JOINT SPACE UPON OPENING THE KNEE CAPSULE. THE CASE WAS A REVISION OF THE KNEE FOR INFECTION WHERE THE SURGEON WAS EITHER REPLACING OR REMOVING PARTS AND WASHING OUT THE KNEE. THE FEMORAL COMPONENT REMAINED IMPLANTED WITHOUT THE CAP AND ONLY THE POLY TIBIAL PLATEAU WAS SWAPPED OUT DURING THE REVISION.
Patient problems: Joint Laxity
MAUDE report 21942171 ↗MalfunctionFeb 18, 2025Component Missing; Positioning Problem; Component Missing; Positioning Problem
THE FEMORAL IMPLANT STOP MADE OF PE WAS MISSING. ANOTHER IMPLANT HAD TO BE OPENED. ISSUE WAS NOTICED BEFORE IMPLANTATION. THE IMPLANT WAS THEREFORE NOT USED. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21394793 ↗InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem
IN A REQUEST FORM FROM DR. M FOR COMPASSION USE REVISION, REFERENCE (B)(4), THE DOCTOR MENTIONS THAT HE SUSPECTED THAT THE POLY AUGMENTS IMPLANTED ON (B)(6) 2021, MAY BE LOOSE. RECEIVED THE POST-OP REPORT ON 01/10/2025, STATING THAT THE TIBIAL COMPONENT SHOWED EVIDENCE OF LOOSENING, THE FEMORAL COMPONENT DID NOT. THE TIBIAL COMPONENT WAS UNDERCUT BELOW THE LEVEL OF THE POLY AUGMENT. REVISION WITH (B)(4) WAS COMPLETED ON OCT. 2, 2024. UNKNOWN DATE OF EVENT. PRE-OP AND POST-OP IMAGING HAS BEEN REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 21320855 ↗InjuryJan 9, 2025Fracture; Fracture
SIDE: LEFT. DIAGNOSIS: FEMORAL SHAFT FRACTURE WITH POSSIBLE METALLOSIS? REVISION OF THE CEMENTED 120MM FEMORAL SHAFT, THE SIZE M FEMORAL COMPONENT, THE SIZE 3 FEMORAL SEGMENT AND THE TIBIAL PLATEAU. THE TIBIA WAS FIRMLY ANCHORED. THE FEMORAL SHAFT IS BROKEN OR FRAGMENTED AT THE DISTAL END OR AT THE ATTACHMENT TO THE FEMORAL CONE IN SEVERAL PLACES. REMOVAL OF THE SHAFT WAS DIFFICULT BECAUSE NO LOOSENING WAS DETECTABLE. THE HOLE FOR SCREW FIXATION WAS WIDENED WITH A DRILL TO ALLOW A REMOVAL HOOK TO BE ATTACHED AND THE STEM TO BE REMOVED WITH A HAMMER. AFTER REMOVAL OF THE STEM, IRRIGATION AND INSERTION OF LOW-VISCOSITY CEMENT, THE FOLLOWING WAS IMPLANTED: FEMORAL COMPONENT 15-2817/12 REPLACEMENT PLATEAU 150027/15 MODULAR STEM 15-2950/06 FEMORAL SEGMENT 15-2978/02 A VERY SATISFACTORY RESULT WAS ACHIEVED.[CUSTOMER].
Patient problems: Failure of Implant; Metal Related Pathology
MAUDE report 21111586 ↗InjuryDec 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NOTIFIED BY REPRESENTATIVE (B)(6) THAT DR. (B)(6) WILL PERFORM A REVISION FOR A FEMUR THAT IT LOOSE. REVISION IS PLANNED FOR (B)(6) 2024. [(B)(6)].
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 20986803 ↗InjuryDec 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NOTIFIED ON 11/27/2024, BY REPRESENTATIVE (B)(6) THAT DR. (B)(6) WILL PERFORM A REVISION FOR A FEMUR THAT IS LOOSE.
Patient problems: Insufficient Information
MAUDE report 20925204 ↗InjuryNov 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NOTIFIED FROM REPRESENTATIVE J.C. THAT A PATIENT WITH A FUSION NAIL HAS LOOSENING OF THE IMPLANT; CONFIRMATION THAT THE FEMORAL STEM IS LOOSE IN THE PROXIMAL FEMUR. IMPLANTED ON (B)(6) 2023. POSSIBLE REVISION WITH A CUSTOM DEVICE.
Patient problems: Joint Laxity
MAUDE report 20589930 ↗
Other WALDEMAR LINK GmbH & Co. KG products
- Unicondylar Sled Prosthesis48 models · 12 reports · 48 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
- Endo-Model Standard Knee Prosthesis System15 models · 19 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.
How reports and recalls are matched · Editorial policy · Report an error on this page