Alloclassic® Zweymüller® 01.00121.040Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024481312), received between Mar 22, 2019 and Nov 19, 2021 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Patient Device Interaction Problem1
Patient problems
- Osteolysis2
- Bone Fracture(s)1
- Foreign Body Reaction1
- Inflammation1
- Local Reaction1
- Metal Related Pathology1
- Necrosis1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT WAS IMPLANTED WITH A DUROM CUP ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO PSEUDOTUMOR, ELEVATED METAL ION LEVELS, OSTEOLYSIS AND WEAR. X-RAYS ALSO SHOW PERIPROSTHETIC FRACTURE ALONG THE FEMUR ON BOTH SIDES WHICH WAS TREATED WITH CERCLAGE.
Patient problems: Metal Related Pathology; Osteolysis
MAUDE report 12842761 ↗InjuryNov 24, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS.
Patient problems: Inflammation; Necrosis
MAUDE report 10895542 ↗InjuryFeb 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN, OSTEOLYSIS, ELEVATED COBALT AND CHROMIUM LEVELS. NOTE: THIS PRODUCT HAS BEEN ADDED AS MAIN PRODUCTS BASED ON INVESTIGATION THAT HAS BEEN DONE ON FEBRUARY 20, 2020.
Patient problems: Foreign Body Reaction; Local Reaction; Osteolysis; Pain
MAUDE report 9768219 ↗InjuryNov 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PLEASE REFER TO REPORT 0009613350 - 2019 - 00157.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8442999 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
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- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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
- 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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