Novation 142-40-63Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
All models of Novation (184)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862537676), received between Apr 28, 2026 and Apr 28, 2026 — classified as 1 injury.
1 FDA recall record name this device's identifier, 1 still open.
2 other recalls cover devices cleared under the same FDA submission (K173583); 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.
Reports received per month
Recalls naming this device
- Dec 31, 2024Open, Classified
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Z-1166-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
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.
InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 70 YO MALE PATIENT, WHO HAD A LEFT THA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 YEAR 1 MONTH POST THE PRIOR PROCEDURE. THE PATIENT HAD A PRIOR SURGERY TO SWAP OUT A RECALLED HIP POLY LINER IN (B)(6) 2025, AND THE PATIENT PRESENTED BACK WITH SIGNS OF A LOCALIZED INFECTION AROUND THE HIP INCISION AND DEEPER. FLUID WAS PULLED FROM THE HIP AND TESTED. THE PATIENT WAS SCHEDULED FOR AN I&D IMPLANT EXCHANGE. THE PATIENT UNDERWENT SURGERY TO WASH OUT THE INFECTED HIP JOINT AND RECEIVE IMPLANT EXCHANGES. ANTIBIOTIC BEADS WERE PLACED INSIDE THE HIP JOINT AS WELL. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.
Patient problems: Unspecified Infection
MAUDE report 25017730 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K173583. One submission often covers many models, so check the product and lot details in each record.
- Z-1165-2025 · Dec 31, 2024 · Open, ClassifiedAcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 AM EHXL 0 LNR G 32MM 140-32-28 AM EHXL 0 LNR H 32MM 140-28-29 AM EHXL 0 LNR J 28MM 140-32-2
- Z-0577-2024 · Nov 21, 2023 · Open, ClassifiedAcuMatch Hip System, Catalog Number 142-32-27
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
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 · each recall links to the FDA recall notice
- 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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