Series 7000Recalls & reported problems across all models
Howmedica Osteonics Corp. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Series 7000 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls
- 1
We found 11 models of Series 7000 by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Jun 23, 2017 and Jul 22, 2026 — classified as 34 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Series 7000 recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0926-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported Series 7000 problems
Device problems
- Insufficient Device Problem Information10
- Loss of Osseointegration9
- Osseointegration Problem9
- Migration4
- Unstable4
- Adverse Event Without Identified Device or Use Problem2
- Degraded1
- Device Damaged Prior to Use1
Patient problems
- Injury19
- Inadequate Osseointegration16
- Pain7
- Insufficient Information3
- Bone Fracture(s)2
- Fall2
- No Consequences Or Impact To Patient2
- Synovitis2
Series 7000 models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Series 7000 7291-0324PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Series 7000 7115-0009PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- Series 7000 7115-0007PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- Series 7000 7115-0005PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- Series 7000 7115-0003PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Series 7000 7115-0004PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Series 7000 7291-0110PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Series 7000 7115-0006PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Series 7000 7115-0011PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Series 7000 7492-0908PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Series 7000 7493-0915PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent Series 7000 adverse event reports
The 15 most recent reports across all models, 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 13, 2024Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration
PATIENT CAME TO DR. IN (B)(6) 2018 WITH COMPLAINTS OF ONGOING LEFT KNEE PAIN FOR ABOUT 1 YEAR. OVER THE LAST YEAR WITH INCREASING INSTABILITY, CLICKING AND BUCKLING FEELING. REVISED TO A TRIATHLON KNEE (B)(6) 2018 WITH COLLAPSED TIBIA NOTED.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 19528876 ↗InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD A REVISION FROM SCORPIO IMPLANTS TO TS KNEE.
Patient problems: Bone Fracture(s); Insufficient Information; Osteolysis
MAUDE report 18158036 ↗InjuryJul 6, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO MECHANICAL LOOSENING (CLARIFIED AS THE TIBIAL BASEPLATE 'TIPPING' INTO VARUS). A SCORPIO KNEE WAS REVISED TO A TRIATHLON TS KNEE. REP PROVIDED REVISION USAGE AND EXPLANT PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Inadequate Osseointegration
MAUDE report 14926713 ↗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 ↗InjuryMay 19, 2022Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED BY THE SALE REP THAT SURGEON INFORMED THAT THERE'S A POSSIBLE REVISION SURGERY FOR KNEE REPLACEMENT DUE TO ASEPTIC LOOSENING AS PATIENT HAD THE KNEE IMPLANT FOR ABOUT 10 YEARS.
Patient problems: Inadequate Osseointegration
MAUDE report 14446463 ↗InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY HEALTH (B)(6) (VIA THE PATIENT) THAT AN INCIDENT REPORT HAD OCCURRED. IT WAS REPORTED THAT THE PATIENT ALLEGED "METALLOSIS WAS CONFIRMED VIA LABS IN (B)(6) 2020". IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NUMBER OF HEALTH CONCERNS.
Patient problems: Foreign Body Reaction
MAUDE report 12335162 ↗InjuryJun 1, 2021Osseointegration Problem; Osseointegration Problem
IN PERFORMING FOLLOW-UP FOR A PI, REP PROVIDED A REVISION OPERATIVE REPORT FOR (B)(6) 2012 FOR THE PATIENT'S RIGHT KNEE. PREOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING RIGHT TOTAL KNEE REPLACEMENT. PATIENT WAS REVISED TO A TRIATHLON TS KNEE. AS PER SALES REP: "NOT SURE WHETHER IT WAS A SCORPIO OR A TRIATHLON."
Patient problems: Inadequate Osseointegration
MAUDE report 11911614 ↗InjuryApr 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED: "SUBSIDED TIBIAL TRAY RIGHT KNEE. REVISED RIGHT KNEE TO REVISION COMPONENTS."
Patient problems: Insufficient Information
MAUDE report 11704557 ↗InjuryApr 21, 2021Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. THE ORIGINAL PLAN WAS TO PERFORM A POLY SWAP. HOWEVER, INTRA-OPERATIVELY, THE TIBIAL COMPONENT WAS FOUND LOOSE. BECAUSE THE SURGEON WANTED A HIGHER LEVEL OF CONSTRAINT, THE ENTIRE SCORPIO CONSTRUCT WAS REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT.
Patient problems: Inadequate Osseointegration
MAUDE report 11699006 ↗InjuryMar 19, 2021Osseointegration Problem; Osseointegration Problem
AS REPORTED: "DR..PERFORMED A RIGHT KNEE REVISION DUE TO LOOSENING." A SENES 7000 TIBIAL COMPONENT, SCORPIO-FLEX TIBIAL INSERT, AND CR FEMORAL COMPONENT WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE LINER, AND THE FEMORAL COMPONENT WAS REVISED TO CONVERT TO A DIFFERENT KNEE SYSTEM. SPOKE TO REP: CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Inadequate Osseointegration
MAUDE report 11523072 ↗InjurySep 24, 2020Loss of Osseointegration; Loss of Osseointegration
RIGHT KNEE REVISION DONE ON (B)(6) 2020 DUE TO TIBIAL COMPONENT LOOSENING. ALL COMPONENTS WERE EXPLANTED. NO RETURN OF EXPLANTED IMPLANTS DUE TO HOSPITAL POLICY. DR. STATED HE WOULD HAVE PREFERRED TO DO A TIBIAL ONLY REVISION SINCE FEMUR WAS WELL FIXED BUT COMPATIBLE BASEPLATES ARE NO LONGER AVAILABLE FROM STRYKER. NO MORE INFORMATION WILL BE AVAILABLE PER DOCTOR.
Patient problems: Inadequate Osseointegration
MAUDE report 10580300 ↗InjuryAug 26, 2020Loss of Osseointegration; Loss of Osseointegration
AS REPORTED: "THE FOLLOWING IMPLANTS WERE EXPLANTED FROM PATIENT'S LEFT KNEE DUE TO LOOSENING. INITIAL IMPLANT DATE WAS (B)(6) 2002. ALL INFORMATION THE FACILITY HAS ON THIS PATIENT IS ATTACHED. A TRIATHLON TS WAS INSERTED." REP PROVIDED PRIMARY USAGE SHEET A SCORPIO/ SERIES 7000 KNEE WAS REVISED.
Patient problems: Injury
MAUDE report 10455335 ↗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 ↗InjuryJun 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE PATIENT HAD AN INFECTION IN A JOINT WHICH HAD PREVIOUSLY BEEN IMPLANTED WITH A SCORPIO NRG. THE JOINT REQUIRED A WASH OUT. THE CUSTOMER REPORTED THAT THE PS POLY NEEDS REPLACING BUT THAT NO REVISION HAS TAKEN PLACE CURRENTLY
Patient problems: Unspecified Infection
MAUDE report 10188984 ↗
Other Howmedica Osteonics Corp. products
- Triathlon608 models · 3,524 reports · 15 recalls
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Accolade57 models · 1,228 reports
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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