Arthrex® AR-1923PHSRecalls & reported problems
Arthrex, Inc. · SUTURE ANCHOR, HIP PUSHLOCK · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867023130), received between Mar 12, 2021 and Oct 10, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Insufficient Device Problem Information1
- Positioning Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
- Rash1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2022Break; Positioning Problem
IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY WITH LABRAL REPAIR THE TIP OF THE ANCHOR BROKE OFF WHILE THE SURGEON TRIED TO INSERT IT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15570117 ↗InjuryMay 24, 2021Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT IS NEEDING TO KNOW THE COMPOSITION OF PRODUCT AR-1923PHS DUE TO HAVING ALLERGIC REACTIONS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 11872273 ↗InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT IS EXPERIENCING A RASH APPROXIMATELY FOUR WEEKS POST OP WHICH WENT AWAY WITH MEDICATION. THE RASH RETURNED IN (B)(6) OF 2020. THE RASH IS RED AND RESEMBLES HIVES AND IT IS IN THE LOCATION OF THE HIP AND SPREADING TO THE UPPER THIGH AND ALSO CAUSING INFLAMMATION THROUGHOUT THE LEG. THE PATIENT HAD A HIP ORTHOSCOPY LATERAL REPAIR (B)(6) 2019. PER THE PATIENT'S COMMENTS, THE RECOVERY WENT AS SCHEDULED UNTIL THE RASH BECAME EVIDENT.
Patient problems: Inflammation; Rash
MAUDE report 11476181 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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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