Scorpio 82-7-0708Recalls & reported problems
Howmedica Osteonics Corp. · Tibial Bearing Insert - PS · Class 2 · Implant
All models of Scorpio (107)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327031003), received between Apr 5, 2019 and Jul 17, 2023 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (3 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
Device problems
- Fracture3
- Adverse Event Without Identified Device or Use Problem2
- Crack1
- Noise, Audible1
- Unstable1
Patient problems
- Injury3
- Pain3
- Ambulation or Postural Difficulties2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAS DONE BILATERAL TKR 13YEARS AGO UNDER. NOW COMPLAINING ABOUT PAIN IN BOTH KNEES. DOCTOR STILL ASSESSING PATIENT'S SITUATION AND YET TO DECIDE THE ROOT CAUSE OF THE KNEE PAIN. REVISION DATE TO BE ADVISED. RIGHT KNEE.
Patient problems: Pain
MAUDE report 17331950 ↗InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD COMPLAINED ABOUT KNEE PAIN 13 YEARS AFTER BILATERAL TKR WAS DONE. DOCTOR IS STILL ASSESSING THE ROOT CAUSE OF PAIN AND YET TO DECIDE ON REVISION. LEFT KNEE.
Patient problems: Pain
MAUDE report 17330149 ↗InjuryFeb 27, 2020Fracture; Fracture
ON (B)(6) 2019 THE PATIENT (WHO HAD INITIAL TKA ON (B)(6) 2017) HAD REVISION SURGERY OF THE RIGHT TIBIAL INSERT AS THE POST OF THE INSERT WAS BROKEN. THE LEFT SIDE OF THE PS TIBIAL INSERT HAD REVISED ON (B)(6) 2019 DUE TO THE SAME REASON THE REPORTING SURGEON REQUESTED TO INVESTIGATE ANY REASONS WHICH CAUSED THE EVENT.
Patient problems: Injury
MAUDE report 9764754 ↗InjuryNov 19, 2019Fracture; Fracture
OUR COMPANY REPRESENTATIVE REPORTED THAT " KNEE SURGERY ON (B)(6) 2015 CAME WITH THE COMPLAINT OF KNEE PAIN. DURING THE REVISION SURGERY ON (B)(6) 2019, DOCTOR REALIZED THAT THE TIBIAL PS INSERT ROSTRUM WAS BROKEN. "
Patient problems: Ambulation or Postural Difficulties; Injury; Pain
MAUDE report 9340568 ↗InjuryApr 5, 2019Crack; Fracture; Unstable; Noise, Audible; Crack; Fracture; Unstable; Noise, Audible
PATIENT WAS REVISED ON (B)(6) 2018 DUE TO BROKEN INSERT. ADDITIONAL INFORMATION IS GOING TO PROVIDE FROM THE CUSTOMER. UPDATE: WHEN THE PATIENT STOOD UP FROM THE CHAIR THE STRANGE NOISE WAS HEARD. REVISION WAS DUE TO INSTABILITY OF KNEE.
Patient problems: Ambulation or Postural Difficulties; Injury
MAUDE report 8486429 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 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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