PRIME P3SBMB48Recalls & reported problems
Microport Orthopedics Inc. · PRIME BIOFOAM MULTI-HOLE SHELL 48 MM GROUP B · Class 2 · Implant
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 00192629280458), received between Aug 3, 2022 and Aug 3, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
Patient problems
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ALLEGEDLY, ON (B)(6) 2022, PATIENT'S CT REVEALED THAT THE P2LELB32 PRIME E-CLASS LINER 15° LIP 32MM GROUP B WAS FOUND TO BE POSSIBLY DISLOCATED. AT THIS TIME, ONLY 3 ITEMS WOULD BE RETURN. #9312; PRIME E-CLASS LINER 15°LIP 32MM GROUP B: P2LELB32 #9313; FEMORAL HEAD BIOLOX® DELTA CERAMIC 12/14 - 32L: PHA04412. #9314; MODULAR NECK AR/VV 1 LONG: PHA01224. JAPAN. (B)(4).
Patient problems: Joint Dislocation
MAUDE report 15155909 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices
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- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 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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