SYNERGY 71306116Recalls & reported problems
Smith & Nephew, Inc. · SYNERGY POROUS HIGH OFFSET FEMORAL COMPONENT SIZE 16 · Class 2 · Implant
All models of SYNERGY (52)
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 03596010292001), received between May 15, 2017 and Jun 17, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Bone Fracture(s)1
- Hip Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT THA ON (B)(6) 2020, PATIENT SUSTAINED A PERIPROSTHETIC FRACTURE AROUND INTERNAL PROSTHETIC LEFT HIP JOINT THAT REQUIRED REVISION SURGERY ON (B)(6) 2020 IN WHICH THE STEM FEM SYNERGY SZ 16, INSERT ACETABULAR OR3O XLPE OD 46 MM ID28 MM 2 MOBILITY AND HEAD FEM TAPER 28MM + 0 WERE EXPLANTED AND EXCHANGED FOR SMITH & NEPHEW BACK-UP DEVICES. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: Hip Fracture
MAUDE report 19554189 ↗InjuryMay 15, 2017Fracture; Fracture
IT WAS REPORTED A RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO PERIPROSTHETIC FRACTURE OF THE PATIENT'S FEMUR AS A RESULT OF THE PATIENT FALLING ON THE OPERATIVE SIDE. STEM WAS REMOVED DURING THE REVISION SURGERY.
Patient problems: Bone Fracture(s)
MAUDE report 6566901 ↗
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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