Series 7000 7115-0005Recalls & reported problems
Howmedica Osteonics Corp. · Standard Tibial Tray · Class 2 · Implant
All models of Series 7000 (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327033342), received between Jun 23, 2017 and Jul 22, 2026 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Loss of Osseointegration2
- Degraded1
- Device Damaged Prior to Use1
- Migration1
- Osseointegration Problem1
Patient problems
- Arthritis1
- Inadequate Osseointegration1
- Injury1
- Insufficient Information1
- Joint Disorder1
- No Consequences Or Impact To Patient1
- No Information1
- Reaction1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2026Loss of Osseointegration
THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A RIGHT SCORPIO KNEE DUE TO TIBIAL LOOSENING AND SUBSIDENCE. HE KEPT THE ORIGINAL PATELLA COMPONENT. HE SAID THE PATIENT MENTIONED IT WAS DONE APPROXIMATELY 22 YEARS AGO.
Patient problems: Inadequate Osseointegration
MAUDE report 25903203 ↗InjuryJun 8, 2022Degraded; Osseointegration Problem; Migration; Degraded; Osseointegration Problem; Migration
ASEPTIC MOBILIZATION OF THE PROSTHESIS. REASON THE DEVICE WAS USED: RIGHT KNEE OSTEOARTHRITIS. TOTAL RIGHT KNEE REPLACEMENT. YEAR OF IMPLANT: 2017.
Patient problems: Arthritis; Insufficient Information
MAUDE report 14634108 ↗InjuryJul 14, 2020Loss of Osseointegration; Loss of Osseointegration
AS REPORTED: "DOCTOR PERFORMED A LEFT KNEE REVISION...DUE TO LOOSENING. IMPLANT NOT ABLE TO BE RETURNED DUE TO HOSPITAL POLICY. NO MORE INFORMATION AVAILABLE PER DOCTOR." A SIZE 5 SERIES 700 TIBIAL TRAY AND 5X12 SCORPIO PS INSERT WERE REVISED.
Patient problems: Injury
MAUDE report 10269655 ↗InjuryDec 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED. THE ORIGINAL DIAGNOSIS WAS ASEPTIC LOOSENING, BUT EFFORT WAS REQUIRED TO REMOVE THE IMPLANTS. SURGEON REPORTED PATIENT FACTORS OF AN EXTREMELY HIGH ACTIVITY LEVEL AND A HISTORY OF NON-COMPLIANCE. THE PATIENT'S CR SCORPIO CONSTRUCT WAS REVISED TO A TRIATHLON TS CONSTRUCT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Joint Disorder
MAUDE report 9416651 ↗MalfunctionJun 6, 2018Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT, DURING A TKA (LEFT SIDE), A SURGEON FOUND A CONVEXED METAL (MIS-PROCESSING) ON THE BASEPLATE. THE BASEPLATE WAS ALREADY CEMENTED SO HE FORCIBLY INSERTED A PE INSERT ON THE BASEPLATE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7573393 ↗InjuryJun 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT HAD A STRYKER RIGHT KNEE REPLACEMENT. PATIENT FELT NORMAL LIFE WAS IMPACTED, RESULTING IN COMPLAINT.
Patient problems: No Information; Reaction
MAUDE report 6663535 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page