Scorpio 76-4013LRecalls & reported problems

Howmedica Osteonics Corp. · Total Stabilizer Femoral · Class 2 · Implant

All models of Scorpio (107)

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 07613327029154), received between Nov 20, 2018 and Nov 20, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K994128); they may or may not involve this specific model.

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.

Most reported problems

Device problems

Naturally Worn1

Patient problems

Injury1

Recent adverse event reports

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

InjuryNov 20, 2018Naturally Worn; Naturally Worn
REVISION TOTAL KNEE ARTHROPLATY FOR OSTEOLYSIS OF MEDIAL FEMORAL CONDOLE. UPDATE 25/OCTOBER/2018: AS REPORTED IN HOW WAS ISSUE NOTICED: PATIENT COMPLAINT AND CONFIRMED BY X-RAY.
Patient problems: Injury
MAUDE report 8090196 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K994128. One submission often covers many models, so check the product and lot details in each record.

Z-0882-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
Z-0877-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
Z-0875-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
Z-0880-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
Z-0876-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
Z-0879-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
Z-0881-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
Z-0878-2024 · Dec 1, 2023 · Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514

Device details

UDI-DI	`07613327029154`
Brand	Scorpio
Model	76-4013L
Company	Howmedica Osteonics Corp.
Product code	JWH · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Class	Class 2
FDA submission	K994128
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 11, 2019

Device type (GMDN): Uncoated knee femur prosthesis, metallic

An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

ATTUNE 1506-00-005
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
589 reports
ATTUNE 1506-00-004
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
580 reports
JOURNEY 74012812
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
502 reports
JOURNEY 74011856
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
438 reports
PERSONA™ 42-5099-094-00
Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
406 reports
JOURNEY 74011857
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
388 reports
ATTUNE 1506-00-007
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
288 reports
ATTUNE 1506-00-003
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
271 reports

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/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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