MobileLink Acetabular Cup System 183-371/32Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · E-Dur® Insert, shouldered 5 mm · Class 2 · Implant
All models of MobileLink Acetabular Cup System (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575177189), received between Oct 17, 2025 and Oct 17, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (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.
Reports received per month
Most reported problems
Device problems
- Positioning Failure2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2025Positioning Failure; Positioning Failure
"NOTIFIED BY (B)(6) ON (B)(6) 2025, THAT 2 MOBILELINK INSERTS WOULD NOT SEAT ONTO THE SHELL DURING A PROCEDURE. THERE WAS APPROXIMATELY A 20 MINUTE DELAY IN THE PROCEDURE. THE 48 MM SHELL (183-101/48) WAS IMPLANTED WITH 2 SCREWS IN PLACE, BUT THE LINER WOULD NOT SEAT CORRECTLY. THERE WAS NO EVIDENCE OF THE SCREWS BEING PROUD. THE SCREWS WERE REMOVED AND THE LINER STILL DID NOT SEAT. AN ADDITIONAL LINER WAS OPENED BUT IT ALSO DID NOT SEAT CORRECTLY. THEN THE SHELL WAS INSTEAD CHANGED TO A TRABECULINK SHELL (183-201/48) BUT NEITHER OF THE 2 LINERS STILL DID NOT SEAT. A 183-361/32 LINER WAS FINALLY USED AND IT SEATED CORRECTLY. THE PARTS IMPLANTED WERE 183-201/48, LOT 220302/0848 WITH 183-361/32, LOT 2323127. THE SHELL AND BOTH INSERTS ARE BEING SHIPPED FOR THE INVESTIGATION." [CUSTOMER]
Patient problems: Insufficient Information
MAUDE report 23320612 ↗MalfunctionOct 17, 2025Positioning Failure; Positioning Failure
"NOTIFIED BY (B)(6) ON (B)(6) 2025, THAT 2 MOBILELINK INSERTS WOULD NOT SEAT ONTO THE SHELL DURING A PROCEDURE. THERE WAS APPROXIMATELY A 20 MINUTE DELAY IN THE PROCEDURE. THE 48 MM SHELL (183-101/48) WAS IMPLANTED WITH 2 SCREWS IN PLACE, BUT THE LINER WOULD NOT SEAT CORRECTLY. THERE WAS NO EVIDENCE OF THE SCREWS BEING PROUD. THE SCREWS WERE REMOVED AND THE LINER STILL DID NOT SEAT. AN ADDITIONAL LINER WAS OPENED BUT IT ALSO DID NOT SEAT CORRECTLY. THEN THE SHELL WAS INSTEAD CHANGED TO A TRABECULINK SHELL (183-201/48) BUT NEITHER OF THE 2 LINERS STILL DID NOT SEAT. A 183-361/32 LINER WAS FINALLY USED AND IT SEATED CORRECTLY. THE PARTS IMPLANTED WERE 183-201/48, LOT 220302/0848 WITH 183-361/32, LOT 2323127. THE SHELL AND BOTH INSERTS ARE BEING SHIPPED FOR THE INVESTIGATION." [CUSTOMER].
Patient problems: Insufficient Information
MAUDE report 23320611 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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