SYNERGY 71306112Recalls & reported problems
Smith & Nephew, Inc. · SYNERGY POROUS HIGH OFFSET FEMORAL SIZE 12 · Class 2 · Implant
All models of SYNERGY (52)
Data updated Oct 18, 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 03596010291967), received between Aug 24, 2017 and Nov 26, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure To Adhere Or Bond1
Patient problems
- Bacterial Infection1
- Metal Related Pathology1
- No Code Available1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BILATERAL PATIENT. PLAINTIFF UNDERWENT MEDICALLY-INDICATED TWO-STAGE REVISION OF THE BHR-THA LEFT HIP IMPLANTS ON (B)(6) 2018. (1ST STAGE) AND (B)(6) 2018 (2ND STAGE). ON THE FIRST STAGE THE STEM, FEMORAL HEAD AND SLEEVE WERE REMOVED. AT THE SECOND STAGE THE ZIMMER COMPONENTS WERE REMOVED ALONG WITH THE BHR-THA SHELL. THE PATIENT REVISION SURGERY WAS PERFORMED DUE TO SEVERE PAIN, LIMITED MOBILITY, METALLOSIS, PSEUDOTUMOR FORMATION, AND ELEVATED COBALT AND CHROMIUM ION LEVELS. NO S&N PARTS REMAINED IMPLANTED.
Patient problems: Bacterial Infection; Metal Related Pathology; Pain
MAUDE report 10909238 ↗InjuryAug 24, 2017Failure To Adhere Or Bond
IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION OF FEMORAL STEM WHICH WAS LOOSE AND HAD SUBSIDED. THE LINER WAS EXCHANGED AND A NEW REVISION STEM WAS PLACED WITH A NEW FEMORAL HEAD.
Patient problems: No Code Available
MAUDE report 6816762 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page