Optetrak Logic 02-012-49-4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10885862174529), received between Aug 28, 2021 and May 14, 2025 — classified as 23 injuries.

The most frequently reported specific device problem is “Naturally Worn” (19 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, STIFFNESS AND DISSATISFACTION WITH THEIR KNEE REPLACEMENT. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION SURGERY, APPROXIMATELY 9 YEARS AFTER INITIAL SURGERY, WHERE THE POLYETHYLENE INSERT WAS EXCHANGED. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 22022612 ↗
• InjuryMar 26, 2025Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  IT WAS REPORTED THAT A 68 YO MALE PATIENT, INITIAL RIGHT TKA IN (B)(6) 2017, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 7 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. THE PATIENT HAD A RECALLED POLYETHYLENE IMPLANT. THE PATIENT WAS SCHEDULED FOR A REVISION TKA, POSSIBLE POLYETHYLENE SWAP. THE PATIENT UNDERWENT A TIBIAL POLYETHYLENE IMPLANT SWAP AND A PATELLA IMPLANT SWAP. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE SENT TO THE LAB AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Discomfort; Loss of Range of Motion; Pain

  MAUDE report 21701609 ↗
• InjuryDec 9, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 7 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20879794 ↗
• InjuryOct 1, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. PATIENT ID: (B)(6) + RIGHT KNEE. RE: EMPLOYEE: (B)(6). EMPLOYER: (B)(6). DATE OF INJURY:(B)(6) 2010. CLAIM NUMBER: (B)(6). TO WHOM IT MAY CONCERN, I AM WRITING TO YOU REGARDING THE ABOVE EMPLOYEE¿S WORKER¿S COMPENSATION CLAIM. MR. MOORE WAS INJURED WHILE WORKING FOR VIRGINIA PUBLIC UTILITIES WHICH REQUIRED RIGHT KNEE SURGERY. THE POLYETHYLENE LINER USED WAS RECALLED BY YOUR COMPANY. THIS REQUIRED MR. MOORE TO HAVE A SECOND SURGERY DUE TO THE RECALL. I HAVE ATTACHED THE SERIAL NUMBERS/INFORMATION RELATED TO THE RECALL. GIVEN THE RECALL, REPEAT SURGERY WAS REQUIRED IN WHICH MEDICAL TREATMENT AND INDEMNITY BENEFITS WERE PAID UNDER MN WORKER¿S COMPENSATION. THE LEAGUE OF MN CITIES INSURANCE TRUST HAVE MADE THE FOLLOWING PAYMENTS UNDER MN WORKER¿S COMPENSATION STATUE: MEDICAL: (B)(6). INDEMNITY: (B)(6). PLEASE CALL ME AT (B)(6) TO DISCUSS OUR CLAIM OR SUBMIT YOUR CHECK IN THE AMOUNT OF $29,429.55, PAYABLE TO THE LEAGUE OF MINNESOTA INSURANCE TRUST AND MAIL IT TO THE ADDRESS BELOW. PLEASE FEEL FREE TO CONTACT ME WITH ANY QUESTIONS. SINCERELY, (B)(6). THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-49-4011 - LOGIC CR TIB INSERT SL

  Patient problems: Insufficient Information

  MAUDE report 20347464 ↗
• InjuryAug 28, 2024Naturally Worn; Naturally Worn

  LEGAL CASE - USA. THIS PATIENT IS VERIFIED LEFT KNEE ON (B)(6) 2017. HE HAD LEFT KNEE REVISION (B)(6) 2023 WITH DR (B)(6). IT WAS REPORTED THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 20091398 ↗
• InjuryAug 20, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO (B)(4). (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 70 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20001368 ↗
• InjuryAug 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 101 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, ASEPTIC LOOSENING AND DEBONDING OF THE FEMORAL COMPONENT, DAILY KNEE PAIN AND DISCOMFORT, LIMITED DAILY ACTIVITIES AND IMPACTED QUALITY OF LIFE. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Osteolysis; Pain

  MAUDE report 19920876 ↗
• InjuryMar 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 5 YEARS AND 1 MONTH AFTER INITIAL IMPLANT DUE TO FAILURE OF RIGHT KNEE WITH RECALLED POLYETHYLENE AND SEVERE OSTEOLYSIS PER REVISION OPERATIVE REPORT RECEIVED. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18814922 ↗
• InjuryFeb 5, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT IN 2015. THIS DEVICE HAS NOT BEEN EXPLANTED. PATIENT IS REPORTING PAIN. THE PATIENT WENT TO AN ORTHOPEDIC SURGEON EARLIER THIS WEEK FOR X-RAYS, AND THE SURGEON WILL PROVIDE GUIDANCE ABOUT SURGERY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Arthralgia; Cyst(s); Insufficient Information; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 18643623 ↗
• InjuryDec 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 76 Y/O MALE PATIENT'S RIGHT KNEE WAS REVISED. THE PATIENT RETURNED TO THE SURGEONS OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2023. THE PATIENT UNDERWENT A POLY INSERT SWAP AND PATELLA IMPLANT SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - IMPLANTS WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. UNABLE TO OBTAIN X-RAYS.

  Patient problems: Failure of Implant

  MAUDE report 18418801 ↗
• InjuryDec 7, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 4 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2020 DUE TO ACCELERATED AND PREVENTABLE WEAR. HOWEVER, DURING THIS PROCEDURE, THE PATIENT WAS RE-IMPLANTED WITH A RECALLED TRULIANT POLYETHYLENE TIBIAL INSERT (SERIAL #:(B)(6)). THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 18282778 ↗
• InjuryNov 28, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 4 YEARS AND 1 MONTH AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023. DIAGNOSIS: POLYETHYLENE WEAR RIGHT KNEE PROTHESIS, SEVERE SYNOVITIS FINDING: PATIENT HAD VERY SEVERE SYNOVITIS OF THE KNEE. IT LOOKS LIKE CASEATING TYPE OF DEBRIS. THERE WAS NO PURULENCE AND THE TISSUE HAD NO EVIDENCE OF INFECTION. THERE WAS A VERY LARGE EFFUSION. THE LINER WAS VERY WORN BOTH MEDIALLY AND LATERALLY. THE POSTERIOR ASPECT OF IT MEDIALLY HAD BROKEN. THERE WAS NO SCRATCHING OF THE TIBIAL OR FEMORAL COMPONENT. PATIENT THEN WOKE FROM IV SEDATION ANESTHETIC WAS TRANSFERRED TO A GURNEY AND TAKEN RECOVERY ROOM.

  Patient problems: Failure of Implant

  MAUDE report 18219681 ↗
• InjuryNov 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE REPORT OF (B)(6) 2023 - PREOPERATIVE DIAGNOSIS- LEFT TOTAL KNEE ARTHROPLASTY WITH PAIN AND INSTABILITY. PROCEDURE -OPEN SYNOVECTOMY AND POLY EXCHANGE. FINDINGS: PATIENT HAD BILATERAL KNEE ARTHROPLASTY. RIGHT KNEE EXCHANGED FOR RECALL. PATIENT HAD PAIN AND INSTABILITY, WITH KNEE SWELLING, ETC,. RULED OUT INFECTION. INTRAOPERATIVELY FOUND LIGAMENTOUS LAXITY WITH 11 POLY AND WENT TO A 15. REVISED TO TRULIANT CRC. THERE IS MENTION OF WEAR OR DEVICE MALFUNCTION. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 18207660 ↗
• InjuryOct 12, 2023Fracture; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Fracture; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST INITIAL LEFT TKA, THE PATIENT RETURNED TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS. FULL REVISION. THE PATIENT HAD REVISION SURGERY AND UNDERWENT A POLY TIBIAL INSERT (TRULIANT CRC TIBIAL INSERT CRC SIZE 4, 12MM) SWAP AND PATELLA (OPTETRAK 3 PEG PATELLA CEMENTED 32MM) IMPLANT SWAP. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE IMPLANT(S) WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

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

  MAUDE report 17926662 ↗
• InjurySep 25, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  PHONE CALL WITH PATIENT: THE PATIENT STATED THAT BOTH KNEE WERE REVISED IN 2015. THE PATIENT STATES THAT HE HAS PAIN IN HIS KNEE. THE PATIENT WENT TO AN ORTHOPEDIC SURGEON FOR X-RAYS, AND THE SURGEON WILL PROVIDE GUIDANCE ABOUT SURGERY. DEVICE HAS NOT BEEN EXPLANTED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17806460 ↗
• InjuryAug 7, 2023Corroded; Naturally Worn; Insufficient Device Problem Information; Corroded; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information; Pain

  MAUDE report 17470357 ↗
• InjuryJul 17, 2023Crack; Fracture; Naturally Worn; Crack; Fracture; Naturally Worn

  X-RAYS WERE OBTAINED WHICH REVEALED BILATERAL JOINT SPACE NARROWING WORSE IN THE MEDIAL COMPARTMENT WHEN COMPARED TO THE LATERAL HOWEVER UPON COMPARISON OF X-RAYS PREVIOUSLY TAKEN THERE WAS CERTAINLY NARROWING IN BOTH THE MEDIAL AND LATERAL COMPARTMENTS. INITIAL LAB WORK WAS DONE IN EFFORTS TO RULE OUT AN INFECTION. INITIAL LAB WORK WAS NOT CONCERNING FOR AN INFECTION AND A RIGHT TOTAL KNEE ARTHROPLASTY REVISION WITH A POLYETHYLENE EXCHANGE WAS SCHEDULED. UPON MAKING THE ARTHROTOMY INCISION COPIOUS AMOUNTS OF STRAW-COLORED JOINT FLUID WITH SOME PLASTIC DEBRIS BEGAN FLOWING OUT OF THE JOINT. IN ADDITION TO THIS THERE WAS SEVERE SYNOVITIS SURROUNDING THE JOINT IN THE PERIOSTEUM BOTH MEDIAL LATERAL AND SUPERIOR. THE SURGEON RECALLED THAT THIS IS THE WORST SYNOVITIS HE HAS SEEN. THE POLYETHYLENE LINER WAS THEN REMOVED. THE POSTERIOR MEDIAL CORNER OF THE POLYETHYLENE LINER HAD FALLEN OFF AND THERE WAS A CRACK IN THE POSTERIOR LATERAL CORNER OF THE POLYETHYLENE LINER. SIGNIFICANT OXIDIZATION COULD BE SEEN ON THE SURFACE OF THE POLYETHYLENE LINER WITH RAPID WHERE BOTH IN THE MEDIAL AND LATERAL ASPECTS OF THE LINER. UPON FURTHER EXPOSING THE KNEE, A 0.5 CM X 4 CM POLYETHYLENE FRAGMENT WAS

  Patient problems: Failure of Implant; Implant Pain; Joint effusion; Swelling/ Edema; Synovitis

  MAUDE report 17332223 ↗
• InjuryFeb 27, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.1 YEARS POST INITIAL RIGHT SIDE TKA, THE 59 Y/O MALE PATIENT HAD A REVISION DUE TO EXTENSIVE SYNOVITIS WAS NOTED, AND OXIDATIVE WEAR BOTH ON THE MEDIAL AND LATERAL ASPECT OF THE POLYETHYLENE. PATIENT HAD A POLY EXCHANGE. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16448850 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED WITH AN OPTETRAK DEVICE ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 4 YEARS 11 MONTHS POST THE INITIAL PROCEDURE FOR REASONS UNKNOWN. THE PLAINTIFF 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. AS A FURTHER DIRECT, PROXIMATE AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE, PLAINTIFF HAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOTIONAL DISTRESS; LOSS OF CONSORTIUM AND PAIN AND SUFFERING. NO DEVICE RETURN ANTICIPATED DO TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16375527 ↗
• InjuryJan 31, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REQUIRED TO UNDERGO REVISION SURGERY DUE TO SEVERE PAIN, SWELLING, AND INSTABILITY IN THE KNEE AND LEG. THESE INJURIES WERE CAUSED BY EARLY AND PREVENTABLE WEAR OF THE POLYETHYLENE INSERT AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS AND OTHER INJURIES. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 16273829 ↗
• InjurySep 16, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, A 59 YO MALE, WHO HAD AN INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS 9 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR UNKNOWN REASONS. POLY SWAP WAS PERFORMED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING AS THE HOSPITAL REFUSED RELEASE OF THE IMPLANT.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Joint effusion; No Clinical Signs, Symptoms or Conditions; Osteolysis; Pain; Subluxation; Swelling/ Edema

  MAUDE report 15438414 ↗
• InjuryJun 9, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL LEFT TKA, THE FEMALE PATIENT HAD A REVISION AS THERE WAS OBVIOUS WEAR ON THE SURFACE OF THE POLY LINER, ALSO, DURING THE CHECK-UP PRIOR TO REVISION SURGERY, THE PATIENT¿S BONE SCAN SHOWED RED SPOTS ON PATELLA. PATIENT HAD SWOLLEN KNEE AND ANTERIOR PAIN. PATIENT WAS REVISE TO A CRC LINER. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND PHOTOS RECEIVED. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14649582 ↗
• InjuryAug 28, 2021Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED APPROXIMATELY 5 YRS POSTOP THE LTKA ON THIS FEMALE PATIENT THE SURGEON COMPLETED A POLY EXCHANGE ON THIS SAME PATIENT. THE POLY THAT WAS REMOVED WAS HEAVILY WORN AND DAMAGED, AND THE SURGEON ASKED THAT IT BE SENT BACK TO THE MANUFACTURER FOR FURTHER EXAMINATION. THE SURGEON SWAPPED THIS IMPLANT FOR A CRC POLY DURING THE REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12381201 ↗

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