SYNERGY 71306111Recalls & reported problems
Smith & Nephew, Inc. · SYNERGY POROUS HIGH OFFSET FEMORAL SIZE 11 · 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 03596010291950), received between Nov 20, 2019 and Nov 26, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Bacterial Infection1
- Failure of Implant1
- Joint Dislocation1
- Metal Related Pathology1
- Pain1
- Unspecified Infection1
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) 2019 (2ND STAGE). ON THE FIRST STAGE ONLY, THE STEM WAS REMOVED AND REPLACE WITH A ZIMMER ONE. AT THE SECOND STAGE THE ZIMMER STEM WAS REMOVED AGAIN ALONG WITH THE BHR-THA SHELL, HEAD AND SLEEVE. 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; Failure of Implant; Joint Dislocation; Metal Related Pathology; Pain
MAUDE report 10908533 ↗InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL THE COMPONENTS WERE REMOVED.
Patient problems: Unspecified Infection
MAUDE report 9349937 ↗
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.
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