Optimized Positioning System (OPS) 1248-1500 and 1248-1700Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09351327000022), received between May 14, 2018 and Nov 11, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS IDENTIFIED THAT THERE WAS AN ERROR WITH THE SUPINE PELVIC TILT MEASUREMENT WHICH HAS RESULTED IN THE OPS ACETABULAR GUIDE BEING MANUFACTURED WITH THE INCORRECT ORIENTATION.

  Patient problems: Insufficient Information

  MAUDE report 20660391 ↗
• InjuryMar 13, 2019Device Dislodged or Dislocated

  PATIENT DISLOCATED 1 WEEK FOLLOWING PRIMARY TOTAL HIP REPLACEMENT (WHILE STILL IN HOSPITAL). IT WAS REPORTED BY THE SURGEON REPRESENTATIVE TO BE AN ANTERIOR DISLOCATION. PATIENT WAS REVISED. THE PRIMARY TOTAL HIP REPLACEMENT SURGERY WAS PERFORMED WITH THE ASSISTANCE OF THE OPS TECHNOLOGIES WHICH INCLUDE OPS ACETABULAR AND FEMORAL PATIENT SPECIFIC GUIDES, DYNAMIC HIP ANALYSIS AND OPS PLAN PRE OPERATIVE REPORTS. THE SURGEON REPORTED THAT THE OPS ACETABULAR GUIDE WAS A GOOD FIT TO THE PATIENT ACETABULUM.

  Patient problems: No Code Available

  MAUDE report 8415766 ↗
• InjuryAug 3, 2018Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON THE (B)(6) 2017. PATIENT REQUIRED REVISION SURGERY DUE TO PSOAS PAIN ON THE (B)(6) 2018. IT WAS FOUND ON THE (B)(6) 2018, THAT THE PATIENT RECEIVED THE OPS ACETABULAR GUIDE DURING PRIMARY SURGERY. IT IS UNKNOWN IF THE OPS ACETABULAR GUIDE WAS USED DURING PRIMARY SURGERY.

  Patient problems: Pain

  MAUDE report 7745972 ↗
• InjuryMay 22, 2018Malposition of Device

  PATIENT REQUIRED REVISION SURGERY DUE TO A SUBLUXING HIP. PRIMARY THA SURGERY WAS PERFORMED WITH THE AID OF THE OPS ACETABULAR GUIDE.

  Patient problems: No Code Available

  MAUDE report 7532520 ↗
• MalfunctionMay 14, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE OPS ACETABULAR PATIENT SPECIFIC GUIDE THAT WAS DELIVERED TO THE SURGEON HAD INCORRECT ORIENTATION.

  Patient problems: Insufficient Information

  MAUDE report 7513242 ↗