Optetrak 200-02-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10885862039583), received between Feb 14, 2020 and Aug 11, 2026 — classified as 49 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (44 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K932690); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 18, 2024Open, Classified

   Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

   Z-2155-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Nov 21, 2023Open, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0582-2024 · Root cause: Packaging change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  Report #3 of 3 for this event.It was reported this patient had an initial right total knee arthroplasty. Subsequently, fourteen (14) years, ten (10) months later, the patient began experiencing worsening symptoms, pain, instability, effusion, and antalgic gate. As a result, the patient required a right total knee revision procedure. An operative report was provided. The patient was revised due to periprosthetic osteolysis of the right knee joint. Intraoperatively, there was significant effusion and synovitis. The tibial insert showed delamination with no evidence of loosening. The femoral component was debonded and removed without significant bone loss. The patella was worn and loose. The patient was revised to another manufacturer's construct. The patient tolerated the procedure well and was transferred to the recovery room in stable condition.Additionally, it was reported via legal documentation the patient continues to experience pain and discomfort on a daily basis in both knees which limits daily activities and quality of life. No further information was reported.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 50208062 ↗
• InjuryJul 28, 2026Naturally Worn

  According to the information provided, the patient underwent a left total knee replacement surgery. Approximately 12 years and 11 months later, the patient had revision surgery on the left knee. All components were removed. Per the Operative Report, the patient presented with significant mechanical loosening and instability of their left primary total knee prosthesis. This was refractory to comprehensive nonoperative management due to extensive polyethylene wear and osteolysis. Because the patient has filed a long form, it appears that they are alleging prosthesis wear, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; soft tissue damage; bone loss; and other injuries presently undiagnosed.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 50058395 ↗
• InjuryMay 22, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY FIFTEEN YEARS POST THE INITIAL LET TOTAL KNEE ARTHROPLASTY, THE PATIENT HAD A REVISION DUE TO POLY ISSUES WITH FLAKING AND DELAMINATION. THE SURGEON REPLACED THE PATELLA AND INSERT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 25258482 ↗
• InjuryMay 21, 2026Naturally Worn

  REPORT 2 OF 2 FOR THIS EVENT. IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THIRTEEN (13) YEARS, SIX (6) MONTHS LATER THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE DUE TO PROSTHESIS WEAR. BOTH THE TIBIAL INSERT AND PATELLA POLYETHYLENE COMPONENTS WERE REPLACED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25247206 ↗
• InjuryApr 20, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A RIGHT KNEE REPLACEMENT. THE PATIENT LATER REQUIRED REVISION SURGERY DUE TO POLYETHYLENE WEAR. THE TIBIAL AND PATELLAR POLYETHYLENE COMPONENTS WERE REVISED, WITH THE PATELLAR COMPONENT DEMONSTRATING MORE SIGNIFICANT WEAR. THIS WAS ASSOCIATED WITH OSTEOLYSIS OF THE BONE, WHICH NECESSITATED BONE GRAFTING. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 24930425 ↗
• InjuryMar 5, 2026Naturally Worn; Lack of Effect

  THE PATIENT PREVIOUSLY UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. THE PATIENT LATER PRESENTED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, STIFFNESS, DECREASED RANGE OF MOTION, AND OVERALL DISSATISFACTION WITH THE KNEE REPLACEMENT. AS A RESULT, THE PATIENT UNDERWENT REVISION SURGERY CONSISTING OF A TIBIAL POLYETHYLENE INSERT AND PATELLAR COMPONENT EXCHANGE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 24524991 ↗
• InjuryDec 17, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 13 YEARS AND 12 DAYS POST, THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MODERATE OSTEOLYSIS WAS PRESENT. THE SURGEON REMOVED ALL OSTEOLYTIC TISSUE. THE PATELLA EXHIBITED SIGNIFICANT WEAR ALONG THE LATERAL AND MEDIAL TRACKING PATH AND HAD DISASSOCIATED FROM THE CEMENT. THE TIBIAL INSERT HAD MILD WEAR ON THE MEDIAL AND LATERAL ARTICULAR SURFACE. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE TIBIAL AND FEMORAL COMPONENTS WERE RETAINED WHILE THE PATELLA AND TIBIAL INSERT COMPONENTS WERE REPLACED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. 200-02-29 - THREE PEG PATELLA 29MM, (B)(6); 244-22-13 - OPTETRAK HI-FLEX TIBIAL INSERT SZ 2 13MM, (B)(6); CONCOMITANTS: 244-03-02 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT (B)(6); 204-04-23 - TRAPEZOID TIBIAL TRAY SZ 1F/3T, 2F/3T (B)(6).

  Patient problems: Osteolysis; Synovitis

  MAUDE report 23827901 ↗
• InjurySep 8, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 99 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POSSIBLE SYMPTOMATIC POLYETHYLENE WEAR, INCLUDING PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. REVISION OPERATIVE NOTES WERE PROVIDED. FINDINGS INDICATED MILD SYNOVITIS AND NO PURULENCE. THERE WAS MILD WEAR OF THE TIBIAL POLYETHYLENE INVOLVING THE POSTERIOR ASPECT, PARTICULARLY ON THE MEDIAL ASPECT, WITH SOME EVIDENCE OF OXIDATION. THE LOCKING MECHANISM APPEARED TO BE INTACT. THE FEMORAL AND TIBIAL COMPONENTS WERE FOUND TO BE WELL-FIXED. THERE WAS ONLY MINIMAL WEAR OF THE PATELLA INVOLVING THE CENTRAL ASPECT. THE SURGEON PERFORMED AN EXCHANGE OF THE TIBIAL AND PATELLA POLYETHYLENE. THE PATIENT WAS THEN AWOKEN FROM SEDATION AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED FOR EVALUATION, AS THEY WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. IMAGES AND X-RAYS WERE PROVIDED FOR REVIEW. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 22994198 ↗
• InjuryAug 15, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE FEMALE PATIENT HAD AN ORIGINAL EXACTECH LEFT TKA. THE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR LEFT 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 ON (B)(6) 2023. THE PATIENT UNDERWENT A LEFT TKA TIBIAL POLY SWAP AND PATELLA IMPLANT SWAP AND REVISED TO A TRULIANT CRC INSERT SIZE 1.5, 13MM AND OPTETRAK 3 PEG PATELLA CEMENTED 29M. THE PATIENT LEFT THE OPERATING ROOM (OR) STABLE. THERE WAS NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE THE IMPLANT WAS REQUIRED TO BE SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 22814268 ↗
• InjuryAug 13, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 12 YEARS POST INITIAL OPERATION. THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE, THERE WAS MILD OSTEOLYSIS PRESENT. THE PATELLA EXHIBITED MILD WEAR ALONG LATERAL TRACKING PATH AND HAD DISASSOCIATED FROM PEGS. THE TIBIAL INSERT HAD MILD WARE MEDIALLY AND LATERALLY BUT THE FEMORAL AND TIBIAL COMPONENT WERE WELL FIXED. OVERALL, THE LINER AND PATELLA WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 22795197 ↗
• InjuryJul 30, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AN 81 YO FEMALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MILD OSTEOLYSIS WAS FOUND PRESENT. THE PATELLA EXHIBITED MEDIAL TO LATERAL WEAR ALONG TRACKING PATH. THE TIBIAL INSERT HAD MILD MEDIAL WEAR. ADDITIONAL WEAR ON THE POSTERIOR POST NOTED. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE PATELLA AND LINER WERE EXCHANGED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED. THERE WAS NO DEVICE IMAGES PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 22671664 ↗
• InjuryJul 11, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 8 YEARS 6 MONTHS POST INITIAL OPERATION. THE PATIENT RETURNED TO SURGEONS OFFICE WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. THE PATIENT HAS A RECALLED POLYETHYLENE IMPLANT. SURGEON PERFORMED A TIBIAL POLYETHYLENE IMPLANT SWAP AND A PATELLA IMPLANT SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT,

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Loss of Range of Motion; Pain

  MAUDE report 22478055 ↗
• InjuryMay 29, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR KNEE REPLACEMENT. AS A RESULT, APPROXIMATELY 6 YEARS, 10 MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION TO REPLACE THE TIBIAL POLYETHYLENE AND PATELLAR IMPLANTS. IT WAS DISCOVERED DURING THE REVISION PROCEDURE THAT THE POLYETHYLENE TIBIAL INSERT WAS BROKEN IN PIECES THAT WERE REMOVED FROM THE POSTERIOR ASPECT OF THE KNEE. ALL OF THE PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL PROLONGATION AS A RESULT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 22107195 ↗
• InjuryMay 12, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 78 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED 10 YEARS POST OP. SURGEON PERFORMED A POLY EXCHANGE ¿ PATELLA LOOSE AND WORN. THE PATIENT WAS REVISED DUE TO POLY WEAR AND PATELLA LOOSENING; THE PATIENT WAS REVISED TO A 35MM PATELLA AND A SZ 3 13MM TIBIAL INSERT. FRAGMENTS OF POLYETHERLEYNE THAT WERE PRESENT IN THE KNEE JOINT WERE REMOVED. THIS TOOK ABOUT 5-15 MINUTES CAUSING NO ADVERSE EVENT AS A RESULT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - IT WAS DISCARDED.

  Patient problems: Insufficient Information

  MAUDE report 22005229 ↗
• InjuryMar 27, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 65 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21712990 ↗
• InjuryMar 21, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL LEFT SIDE TKA, THE PATIENT PRESENTED BACK AND WAS SCHEDULED FOR A REVISION OF THE TOTAL KNEE POSSIBLE POLY SWAP DUE TO POLY WEAR, FAILURE, AND RECALL. A TIBIAL INSERT POLY SWAP AND A PATELLA IMPLANT REVISION WERE PERFORMED. THERE WAS A 30-45 MINUTES SURGICAL DELAY/PROLONGATION; HOWEVER, PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF SURGICAL PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21664473 ↗
• InjuryMar 21, 2025Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 171 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, INSTABILITY, AMBULATION DIFFICULTIES, DISCOMFORT, JOINT EFFUSION, JOINT LAXITY, OSTEOLYSIS, PAIN, SWELLING/EDEMA AND SYNOVITIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21662653 ↗
• InjuryMar 19, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 13 YEARS AND 7 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A LINER AND PATELLA EXCHANGE. THE PATIENT'S MAIN COMPLAINT WAS DISCOMFORT AND PAIN AROUND THE PATELLA. EXCHANGE OF THE TIBIAL LINER WAS MORE DUE TO THE SURGEON ALREADY BEING IN THERE. THERE WAS NO SIGN OF OSTEOLYSIS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Discomfort; Limb Fracture; Pain

  MAUDE report 21643120 ↗
• InjuryMar 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY, APPROXIMATELY 4 YEARS, 10 MONTHS AFTER INITIAL IMPLANT THE PATIENT HAD A REVISION SURGERY. REVISION OPERATIVE REPORT POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE. PATELLA WAS REVISED TO AN OPTETRAK 3 PEG PATELLA, 32 MM DIAMETER AND A TRULIANT POLYETHYLENE LINER WAS PLACED. PATIENT EXPERIENCED PAIN AND SWELLING; IMAGING WAS CONSISTENT WITH POSSIBLE SYMPTOMATIC POLYETHYLENE WEAR. THE POLYETHYLENE WAS REMOVED AND SHOWED OXIDATION AND MILD WEAR. THERE WAS NO LOOSENING NOTED WITH IMPACTION. PATIENT WAS THEN WOKEN FROM SEDATION AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21633096 ↗
• InjuryMar 10, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 15 YEARS AND 10 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MILD OSTEOLYSIS WAS PRESENT. PATELLA EXHIBITED SEVERE WEAR ALONG TRACKING PATH. THE TIBIAL INSERT HAD MILD WEAR MEDIALLY AND POSTERIORLY. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE PATELLA AND LINER WERE EXCHANGED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 21560183 ↗
• InjuryMar 7, 2025Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL BRIEF, ON (B)(6) 2012, PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING AN OPTETRAK LOGIC CC TIBIAL INSERT. PATIENT WILL UNDERGO REVISION SURGERY ON (B)(6) 2023. FOLLOWING THE REVISION SURGERY, PATIENT WILL CONTINUE TO BE LIMITED IN HER ACTIVITIES OF DAILY LIVING. PATIENT HAS DIFFICULTY WITH DAILY ACTIVITIES SUCH AS GETTING DRESSED, CLIMBING STAIRS, AND BATHING. DESPITE UNDERGOING THE REVISION SURGERY, PATIENT WILL LIKELY EXPERIENCE DAILY PAIN AND DISCOMFORT IN HER LEFT KNEE WHICH LIMITS HER ACTIVITIES OF DAILY LIVING AND IMPACTS HER QUALITY OF LIFE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Cyst(s); Discomfort; Pain; Synovitis

  MAUDE report 21550525 ↗
• InjuryMar 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 43 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, LOOSE FEMORAL COMPONENT, SYNOVITIS, OSTEOLYSIS, PAIN, AND INSTABILITY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 21525311 ↗
• InjuryFeb 24, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A 80 YO FEMALE PATIENT HAD AN ORIGINAL LEFT TKA. THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. THE PATIENT HAS A RECALLED POLYETHYLENE IMPLANT. THE PATIENT WAS SCHEDULED FOR A REVISION TKA POSSIBLE POLYETHYLENE SWAP. THE PATIENT HAD REVISION SURGERY IN (B)(6) 2025. THE PATIENT UNDERWENT A TIBIAL POLYETHYLENE IMPLANT SWAP AND A PATELLA IMPLANT SWAP. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE AVAILABLE. 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: Ambulation or Postural Difficulties; Pain

  MAUDE report 21454275 ↗
• InjuryFeb 20, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.4 YEARS POST INITIAL LEFT TKA, THE 72 Y/O FEMALE 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 VERSUS FULL REVISION. THE PATIENT UNDERWENT A REVISION TKA WITH A POLY SWAP AND PATELLA SWAP. PATENT WAS REVISED TO TRULIANT CRC TIBIAL INSERT SZ 2, 15MM AND OPTETRAK 3 PEG PATELLA CEMENTED 32MM. PATIENT HAD POLY DEBRIS. THERE WAS NO 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 WAS SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21420430 ↗
• InjuryJan 27, 2025Naturally Worn; Naturally Worn

  LEGAL CASE: (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2013. THEY HAD RIGHT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 9 YEARS 6 MONTHS AFTER THEIR INITIAL PROCEDURE. ON (B)(6) 2023, (B)(6), RN/ REVISION OPERATIVE REPORT ON (B)(6) 2023- FAILED RIGHT KNEE REPLACEMENT. THE SPACER WAS COMPLETELY WORN OUT MEDIALLY AND SOMEWHAT LATERALLY, POSTERIORLY. AFTER THE FEMUR WAS TAKEN OUT, THE TIBIA POPPED OUT ON ITS OWN. ALL DEBRIS WAS REMOVED. THE PATELLA WAS REMOVED, IT WAS COMPLETELY WORN. HOSPITAL CARE: ADMITTED ON (B)(6) 2023; DISCHARGED 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. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS.

  Patient problems: Failure of Implant

  MAUDE report 21246442 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932690. One submission often covers many models, so check the product and lot details in each record.

• Z-2156-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
• Z-2157-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
• Z-2158-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
• Z-0019-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200