Arthrex® AR-13070M-SRecalls & reported problems
Arthrex, Inc. · PATELLA SUTPLT II STAR M STRL · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867279452), received between Jan 24, 2022 and Jan 24, 2022 — classified as 1 injury.
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
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Fracture1
Patient problems
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 24, 2022Break; Fracture; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT AN ARTHREX PLATE FROM THE LOANER SET MTH-14120-PATPLATE2 // 403793667 WAS IMPLANTED IN AN ELDERLY PATIENT. THE PLATE BROKE POST-OP DUE TO A FALL ON THE OPERATED KNEE. A NEW LOANER SET WAS ORDERED TO PERFORM A REVISION SURGERY. UPDATE 04-JAN-2022: FURTHER INFORMATION WAS PROVIDED THAT THE ARTHREX PLATE IS NOT BROKEN. AS A RESULT OF THE FALL, THE DISTAL POLE OF THE PATELLA IS ALSO FRACTURED, MEANS THE INITIAL FRACTURE HAS WIDENED. DUE TO THE NEW FRACTURE CONDITIONS, IT WAS NECESSARY TO CHANGE TO A NEW ARTHREX IMPLANT, PATELLA SUTURE PLATE WITH HOOK FOR POLE REFIXATION. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021 THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2021.
Patient problems: Fall
MAUDE report 13333358 ↗
Other Plate, fixation, bone devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page