NA 55085Recalls & reported problems
Smith & Nephew, Inc. · Starlock - Array Adaptor · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556909348), received between Sep 5, 2024 and Jul 31, 2025 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, ONE (1) STARLOCK ARRAY ADAPTOR BROKE AT THE CONNECTOR DURING THE IMPLANTATION STAGE OF THE ACETABULAR SHELL. ALL METAL PARTS WERE RETRIEVED USING A LONG NOSE KOUGHER. X-RAYS RECONFIRMED THAT NO PIECES WERE LEFT INTO THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY USING THE SAME DEVICE HOLDING IT TIGHT, AND NO INJURIES WERE REPORTED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22682499 ↗MalfunctionSep 5, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, THE INSTRUMENT ADAPTER STARLOCK V2012 THAT GO ON THE CUP HANDLE WERE BENT. AFTER CASE, IT WAS CHECKED AGAIN AND THE ARRAY WAS ABLE TO BE SEEN IF POINTED THE ARRAYS TOWARDS THE CEILING MEANING THAT THE ARRAY BENT. SURGEON DID NOT USE CUP NAVIGATION AND RETURNED TO USE THE LEG LENGTH AND OFFSET. SURGERY WAS PERFORMED, CHANGING TO MANUAL INSTRUMENTATION. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20150807 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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