SimplexRecalls & reported problems across all models
Howmedica Osteonics Corp. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 146
- Deaths reported
- 5
- Injuries reported
- 77
- Recalls
- 0
We found 4 models of Simplex by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 146 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2017 and Sep 10, 2026 — classified as 5 deaths, 77 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (33 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. 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
Most reported Simplex problems
Device problems
- Insufficient Device Problem Information33
- Adverse Event Without Identified Device or Use Problem19
- Break16
- Device Difficult to Setup or Prepare16
- Loss of Osseointegration15
- Leak/Splash11
- Patient Device Interaction Problem11
- Osseointegration Problem9
Patient problems
- No Consequences Or Impact To Patient31
- Inadequate Osseointegration23
- Pain20
- Injury16
- No Patient Involvement14
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient10
- Cardiac Arrest7
Simplex models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Simplex 6191-1-001BONE CEMENT3 deaths76 reports
- Simplex 6197-9-001BONE CEMENT2 deaths57 reports
- Simplex 6192-1-001BONE CEMENT10 reports
- Simplex 6188-1-001BONE CEMENT3 reports
Recent Simplex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50722470 ↗InjuryJan 8, 2026Loss of Osseointegration
InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED VIA MEDWATCH MW5172706: INCREASING SYMPTOMATIC INCISIONAL VENTRAL HERNIA.
Patient problems: Hernia
MAUDE report 22882028 ↗MalfunctionJun 26, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
AS REPORTED VIA MEDSUN (B)(4): BONE CEMENT WAS OPENED TO THE FIELD. ALL PREP WAS COMPLETED CORRECTLY BY THE SURGICAL TECH. SURGEON NOTICED BONE CEMENT WAS HARDENING RAPIDLY. TYPICALLY, THE BONE CEMENT DOESN'T HARDEN AS FAST AS IT DID IN THIS CASE (SIMPLEX P HARDENED UNDER 9 MINUTES). DUE TO THE CEMENT HARDENING FASTER THAN USUAL, IT CAUSED THE CASE TO GO OVER TIME. SURGEON HAD TO REMOVE SOME OF THE CEMENT TO CORRECTLY PLACE THE IMPLANTS. SURGEON STATED, "THE CEMENT OPENED WAS A BAD BATCH."
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22336091 ↗MalfunctionMay 29, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT UPON INSPECTION, THE STERILIZATION DOT OF 2 DOSES OF CEMENT WERE YELLOW/ GOLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22103698 ↗MalfunctionMay 29, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT UPON INSPECTION, THE STERILIZATION DOT OF 2 DOSES OF CEMENT WERE YELLOW/ GOLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22103695 ↗InjuryMay 19, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL LOOSENING. THE FEMUR AND INSERT WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Inadequate Osseointegration
MAUDE report 22042709 ↗InjuryMay 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED VIA MEDWATCH MW5168818: STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE MILD SWELLING. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: POSSIBLY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22.
Patient problems: Swelling/ Edema
MAUDE report 22042704 ↗InjuryMay 19, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL LOOSENING. THE FEMUR AND INSERT WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Inadequate Osseointegration
MAUDE report 22042703 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED VIA MEDWATCH MW5168819: CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE MILD SWELLING.
Patient problems: Swelling/ Edema
MAUDE report 22025438 ↗InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL ADVERSE EVENT RECEIVED FOR R ANTERIOR KNEE PAIN. DEVICE RELATEDNESS: POSSIBLY RELATED. PROCEDURE RELATEDNESS: DEFINITELY RELATED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Patient problems: Pain
MAUDE report 21112276 ↗InjuryDec 16, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE TIBIA AND FEMUR. INTRA-OPERATIVELY, IT WAS ALSO OBSERVE THAT BOTH STEMS (TIBIAL AND FEMORAL) BROKE OFF APPROXIMATELY HALFWAY UP THEIR THREADING. THE PATIENT'S TS KNEE WAS CONVERTED TO A COMPETITOR REVISION KNEE (PATELLAR COMPONENT WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Inadequate Osseointegration
MAUDE report 20937363 ↗InjuryDec 16, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE TIBIA AND FEMUR. INTRA-OPERATIVELY, IT WAS ALSO OBSERVE THAT BOTH STEMS (TIBIAL AND FEMORAL) BROKE OFF APPROXIMATELY HALFWAY UP THEIR THREADING. THE PATIENT'S TS KNEE WAS CONVERTED TO A COMPETITOR REVISION KNEE (PATELLAR COMPONENT WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Inadequate Osseointegration
MAUDE report 20937359 ↗InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED VIA MW5161062: CLINICAL ADVERSE EVENTS RECEIVED FOR ABDOMINAL PAIN DEVICE AND PROCEDURE (RELATEDNESS).
Patient problems: Pain
MAUDE report 20818400 ↗InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2008 AND WAS REVISED ON (B)(6) 2010. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. AS PER MEDICAL REVIEW: "THE IMPLANT RECORD AND OPERATIVE REPORT CONFIRM A REVISION THA WAS PERFORMED FOR LOSS OF ACETABULAR FIXATION WITH CHANGE IN COMPONENT POSITION IN A CEMENTED THA. NO DOCUMENTATION WAS PROVIDED REGARDING INCREASED METAL ION LEVELS." MEDICAL RECORD: "[...] FOLLOWUP RADIOGRAPH OF THE HIP WAS OBTAINED AND THERE WAS OBVIOUS CHANGE IN POSITION OF THE ACETABULAR COMPONENT WITH LOSS OF FIXATION OF THE CEMENT. [...]".
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 20799124 ↗
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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