MP Reconstruction Prosthesis 172-921/14Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · Hip Prosthesis Stem,Size 001 · Class 2 · Implant
All models of MP Reconstruction Prosthesis (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575210701), received between Mar 17, 2026 and Mar 30, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K142187); 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
Most reported problems
Device problems
- Fracture2
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Fracture
NOTIFIED BY A REPRESENTATIVE WHO WAS IN A PROCEDURE FOR AN EXTRACTION OF A DISTAL STEM FRACTURE. THE STEM WAS IMPLANTED IN 2014. THE REVISION WAS NOT A LINKBIO PRODUCT.
Patient problems: Failure of Implant
MAUDE report 24728219 ↗InjuryMar 17, 2026Fracture
NOTIFIED BY A REPRESENTATIVE WHO WAS IN A PROCEDURE FOR AN EXTRACTION OF A DISTAL STEM FRACTURE. THE STEM WAS IMPLANTED IN 2014. THE REVISION WAS NOT A LB PRODUCT.UNKNOWN EVENT DATE. THE EXTRACTED PRODUCT WAS DISCARDED. "[CUSTOMER]"
Patient problems: Insufficient Information
MAUDE report 24615507 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142187. One submission often covers many models, so check the product and lot details in each record.
- Z-0769-2025 · Dec 5, 2024 · Open, ClassifiedLINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 I
- Z-0733-2019 · Dec 7, 2018 · TerminatedLINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK STEM with Microporo
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
- 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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