Optetrak Logic 02-012-48-3009Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862174383), received between Jan 4, 2022 and Sep 18, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K111400); they may or may not involve this specific model.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 91 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND DISCOMFORT, SWELLING, MOBILITY IMPAIRMENTS, BONE DETERIORATION, CYSTS; ONGOING MEDICAL CARE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Cyst(s); Discomfort; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20249504 ↗
• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 93 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, INJURIES, PAIN AND DEBILITATION, OTHER INJURIES PRESENTLY UNDIAGNOSED; INCURRED EXPENSES FOR DOCTORS, HOSPITALS, NURSES, AND OTHER REASONABLY REQUIRED AND MEDICALLY NECESSARY SUPPLIES AND SERVICES, WHICH SAID SERVICES ARE STILL CONTINUING; UNABLE TO ATTEND REGULAR EMPLOYMENT, DIMINISHED EARNING CAPACITY; SPECIAL (ECONOMIC) DAMAGES; GENERAL (NON-ECONOMIC) DAMAGES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain

  MAUDE report 19650088 ↗
• InjuryJun 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 55 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, TISSUE AND BONE LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 19462436 ↗
• InjuryAug 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 6 YEARS POST OP INITIAL LEFT TKA, THIS 79 Y/O FEMALE PATIENT WAS REVISED. SURGEON PERFORMED A POLY SWAP OF THE RECALLED POLY. REASON FOR THE REVISION WAS NOT REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS AVAILABLE. DEVICE NOT RETURNING HOSPITAL KEPT.

  Patient problems: Failure of Implant

  MAUDE report 17478811 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF, ON (B)(6) 2016 PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING AN INSERT MADE OF POLYETHYLENE. PATIENT UNDERWENT REVISION SURGERY OF HER LEFT KNEE ON (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 16264849 ↗
• InjuryNov 30, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS 75 YEAR OLD FEMALE PATIENT HAD A RIGHT TKA 6 YEARS AGO. SHE HAD GREAT PAIN RELIEF FOR 4 YEARS THEN NOTICED INCREASING PAIN AND SWELLING OVER THE LAST 2 YEARS. SHE RECEIVED A LETTER REGARDING THE RECALL AND PRESENTED TO HER SURGEON WITH PAIN AND INSTABILITY. THE PATIENT WAS REVISED AT AN UNKNOWN DATE WITH A POLYETHYLENE EXCHANGE AND A SYNOVECTOMY. NO SEVER OSTEOLYSIS. COMPLETE REVISION CONDYLAR CONSTRAINED: FEMORAL OSTEOLYSIS, TIBIAL OSTEOLYSIS. COMPLETE REVISION REQUIRING HINGE.

  Patient problems: Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15888096 ↗
• InjuryNov 21, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST INITIAL TKA, THE FEMALE PATIENT FEMUR HAD AN INCREASED POSTERIOR DWELL POINT- WHETHER THE SLOPED POLY OR A COMPROMISED PCL WAS THE ROOT CAUSE IS UNCLEAR. THIS LIKELY LED TO THE EARLY DELAMINATION OF THE POSTEROLATERAL ASPECT OF THE POLY BEARING. THERE WAS ALSO SIGNIFICANT OSTEOLYSIS UNDER THE POSTERIOR CONDYLES- ALTHOUGH THE FEMUR WASN¿T GROSSLY LOOSE. PATIENT WAS REVISED TO A COMPETITOR'S DEVICES. PER SALES REP "WE HAVE SEEN A SIMILAR TREND IN OUR COMPLAINTS/RETRIEVAL DATABASE OF AGED/SLOPED CR POLY BEARINGS."

  Patient problems: Failure of Implant

  MAUDE report 15834337 ↗
• InjurySep 7, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 69 Y/O FEMALE PATIENT'S RIGHT KNEE HAD A POLY SWAP. STRAIGHT FORWARD SWAP- NO INCIDENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING, HOSPITAL WILL NOT RELEASE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Pain

  MAUDE report 15372666 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS 86 YEAR OLD, 45 KG., FEMALE PATIENT HAD A RIGHT TKA ON (B)(6) 2016. THE PATIENT PRESENTED TO THE HOSPITAL WITH INFECTION. A BACTERIAL PATHOGEN WAS IDENTIFIED AS E-COLI. THE PATIENT WAS BOOKED FOR SURGERY FOR A DEBRIDEMENT, WASH-OUT, AND LINER EXCHANGE ON (B)(6) 2022. THE CR SLOPE + 9MM INSERT WAS REMOVED. THERE WAS NO REPORTED BREAKAGE OF DEVICES OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING AS IT WAS DISPOSED OF.

  Patient problems: Bacterial Infection

  MAUDE report 15121514 ↗
• InjuryMay 17, 2022Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY THREE YEARS POST INITIAL TKA, THE (B)(6)FEMALE PATIENT WAS DIAGNOSED WITH FAILED RIGHT TOTAL KNEE ARTHORPLASTY AND UNDERWENT REVISION SURGERY. DURING THE REVISION SURGERY, PATIENT'S SURGEON STATED, "PATIENT HAD A PREVIOUS RIGHT TOTAL KNEE ARTHROPLASTY. THIS HAD FAILED SECONDARY TO CATASTROPHIC POLYETHYLENE WEAR. THIS CREATED LARGE CYSTS WITHIN BOTH THE MEDIAL AND LATERAL POSTERIOR CONDYLES, AS WELL AS THE MEDIAL ASPECT OF THE PROXIMAL TIBIA. SURGEON REMOVED THE POLYETHYLENE, WHICH WAS NOTED LO HAVE SEVERE POLYETHYLENE WEAR." FOLLOWING THE REVISION SURGERY, PATIENT CONTINUES TO BE LIMITED IN PATIENT'S ACTIVITIES OF DAILY LIVING. PATIENT HAS DIFFICULTY WITH DAILY ACTIVITIES SUCH AS GETTING DRESSED, CLIMBING STAIRS, AND BATHING. AS A DIRECT RESULT, PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Discomfort; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 14421190 ↗
• InjuryApr 26, 2022Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY THREE YEARS POST INITIAL TKA, THIS (B)(6) MALE PATIENT UNDERWENT REVISION SURGERY DUE TO POLYTHYLENE FAILURE. DURING REVISION SURGERY, IT WAS NOTED THAT THE POLYETHYLENE FROM THE TIBIAL TRAY AND IT WAS FRACTURED POSTEROMEDIALLY AND HAD SOME PITTING THROUGHOUT THE MEDIAL AND LATERAL ASPECT AND SOME WEARING DOWN OF THE MEDIAL PLATEAU. DESPITE UNDERGOING REVISION SURGERY, PATIENT EXPERIENCES DAILY PAIN AND DISCOMFORT IN RIGHT KNEE WHICH LIMITS PATIENT¿S ACTIVITIES OF DAILY LIVING AND IMPACTS PATIENT QUALITY OF LIFE.

  Patient problems: Failure of Implant

  MAUDE report 14212008 ↗
• InjuryJan 4, 2022Naturally Worn; Naturally Worn

  AS REPORTED, A (B)(6) FEMALE PATIENT HAD A REVISION DUE TO EFFECTED POLY CAUSING POLY WEAR WITHIN 15 MONTHS. PATIENT'S LINER WAS REPLACED. THERE WAS NO BREAKAGE OF THE DEVICE. THERE WAS NO SURGICAL DELAY OR PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 13159742 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013