Arthrex® AR-501-TTLDRecalls & reported problems

Arthrex, Inc. · IBAL UKA TIB TRAY SZ 4,LFT-MEDIAL/RL · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867034150), received between Oct 20, 2023 and Oct 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryOct 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ON (B)(6) 2022, IT WAS REPORTED BY THROUGH A PATIENT'S LEGAL FILING THAT ON (B)(6) 2017 THE PATIENT UNDERWENT A LEFT KNEE UNI-COMPARTMENTAL KNEE ARTHROPLASTY. DURING THE PROCEDURE THE SURGEON IMPLANTED AN ARTHREX IBALANCE UNI-COMPARTMENTAL KNEE SYSTEM WITH A SIZE 3 FEMORAL COMPONENT, SIZE 4 TIBIAL TRAY, AND AN 8 MM TIBIAL BEARING INSERT INTO THE LEFT KNEE MEDIAL PARAPATELLAR FACETECTOMY. THEREAFTER THE PATIENT WAS HAVING PAIN IN THE LEFT KNEE AND ON (B)(6) 2019 AN MRI OF THE KNEE WAS TAKEN WHICH REVEALED ¿METALLIC ARTIFACT IS PRESENT INVOLVING THE MEDIAL COMPARTMENT OBSCURING AND DISTORTING THE UNDERLYING AND ADJACENT STRUCTURES.¿ ON (B)(6) 2019 THE PATIENT REPORTED A CRUNCHING SENSATION ON THE MEDIAL ASPECT OF THE KNEE. ON (B)(6) 2019 AND AGAIN ON (B)(6) 2020 THE PATIENT COMPLAINED OF ACHES, PAINS AND WEAKNESS IN THE KNEE. ON (B)(6) 2020 THE PATIENT PRESENTED TO ANOTHER SURGEON AND A BONE SCAN WAS ORDERED WHICH REVEALED A LOOSE IMPLANT. THE PATIENT WAS REFERRED TO ANOTHER SURGEON TO DISCUSS REVISION OPTIONS DUE TO LOOSENING OF THE IMPLANT AND ON (B)(6), 2020 THAT SURGEON PERFORMED AN EXPLANTATION AND ANTIBIOTIC SPACER PLACEMENT, LEFT TOTAL KNEE ARTHROPLASTY AND SAUCERIZATION OF FE
Patient problems: Unspecified Infection
MAUDE report 17980950 ↗

Device details

UDI-DI	`00888867034150`
Brand	Arthrex®
Model	AR-501-TTLD
Company	Arthrex, Inc.
Product code	HSX · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jan 9, 2024

Device type (GMDN): Unicondylar knee prosthesis

A sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.

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All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
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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