Optetrak 200-02-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 10885862039613), received between Dec 7, 2020 and Jun 4, 2026 — classified as 100 injuries.

The most frequently reported specific device problem is “Naturally Worn” (79 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 100 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS AND 3 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PROSTHESIS WEAR, FRACTURE, INSTABILITY AND LOOSENING. PER THE PROVIDED OPERATIVE REPORT, THERE WAS A SIGNIFICANT AMOUNT OF SYNOVITIS, WHICH WAS REMOVED. THE POLYETHYLENE SHOWED A SIGNIFICANT AMOUNT OF WEAR AT THE POST, AS WELL AS POSTERIOR LATERALLY WHERE IT FRACTURED. THE PATELLA WAS ALSO FOUND TO HAVE A SIGNIFICANT AMOUNT OF WEAR. THERE WERE SEVERAL SMALL FRAGMENTS OF POLYETHYLENE THAT WERE FLOATING ABOUT THE KNEE. BECAUSE THE PATIENT HAS FILED A LONG FORM, IT APPEARS THEY ARE ALLEGING SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; METALLOSIS; SOFT TISSUE DAMAGE; INFECTION; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 25391647 ↗
• InjuryFeb 25, 2026Naturally Worn

  THE SURGEON BOOKED ANOTHER COMPANY'S REVISION GEAR IF THE INTRAOPERATIVE FINDINGS SHOWED LOOSE FEMUR AND TIBIAL COMPONENTS. ON ASSESSMENT, BOTH COMPONENTS WERE FOUND TO BE LOOSE, NECESSITATING A FULL REVISION. THE TIBIAL POLY INSERT DEMONSTRATED MODERATE WEAR, WHILE THE PATELLAR POLY SHOWED SOME WEAR, THOUGH LESS SIGNIFICANT.

  Patient problems: Insufficient Information

  MAUDE report 24442700 ↗
• InjuryDec 2, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE SURGEON NEEDED TO PERFORM A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. THERE WAS MINIMAL OSTEOLYSIS PRESENT, BUT THE PATELLA EXHIBITED SEVERE WEAR ALONG LATERAL TRACKING PATH AND HAS DISASSOCIATED FROM BONE. THE TIBIAL INSERT HAD MILD WEAR ON THE MEDIAL AND LATERAL ARTICULAR SURFACES, AND POSTERIOR OF POST. THE FEMORAL AND TIBIAL COMPONENT WERE WELL FIXED. THE SURGEON DECIDED TO KEEP THE TIBIAL AND FEMORAL COMPONENTS RETAINED WHILE THE PATELLA AND TIBIAL INSERT COMPONENTS WERE REPLACED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 23699840 ↗
• InjuryNov 24, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MILD OSTEOLYSIS WAS PRESENT. THE PATELLA EXHIBITED SEVERE WEAR ALONG THE LATERAL TRACKING PATH. THE TIBIAL INSERT HAD SEVERE WEAR ON THE MEDIAL AND LATERAL ARTICULAR SURFACE, AND POSTERIOR OF POST. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE TIBIAL AND FEMORAL COMPONENTS WERE RETAINED WHILE THE PATELLA AND TIBIAL INSERT WERE REPLACED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 23632153 ↗
• InjuryNov 19, 2025Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATELLA COMPONENT WAS NOT REVISED.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 23594399 ↗
• InjuryNov 17, 2025Noise, Audible; Migration; Noise, Audible; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED THAT THEY CAN NO LONGER WALK DUE TO A RECALLED PATELLA THAT IS MOVING AND MAKING NOISE. AS A RESULT, THE PATIENT'S SURGEON INFORMED THEM ANOTHER SURGERY WOULD BE REQUIRED ON A FUTURE DATE. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 23571004 ↗
• InjuryNov 6, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN. THE SURGEON REVISED THE PATELLA DUE TO WEAR AND PITTING. HE ALSO DID A POLY SWAP GOING FROM A 11MM TO 12MM PS POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 23492307 ↗
• InjurySep 4, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED AND THEN UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. REASON FOR REVISION INDICATED INSTABILITY WITH THE PATELLA, CLICKING, AND THE POLY RECALL. THE PATIENT WAS REVISED TO A SIZE 4 CONSTRAINED FEMUR WITH AN 18 X 1 20 STEM A MEDIUM 32 CONE AND A 4\19 MM CONSTRAINED POLY. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE NOT MADE AVAILABLE. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. DEVICE IMAGES, EBI SURGERY RESULTS, & QAD SERIAL TRACE ATTACHED. NO X-RAYS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 22961665 ↗
• InjurySep 3, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 138 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PERSISTENT EFFUSIONS, WEIGHTBEARING PAIN, A LOOSE FEMUR AND RECALLED POLY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PRE-OP X-RAYS SHOWED LARGE EFFUSION AND OSTEOLYSIS AROUND THE PERIPHERY OF THE TIBIAL AND FEMORAL COMPONENTS. THE PATELLA WAS FOUND TO BE DELAMINATED WITH YELLOW OXIDATION. THE FEMORAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE. THE TIBIAL COMPONENT WAS WELL-FIXED. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. IMAGES AND X-RAYS WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Joint effusion; Osteolysis; Pain

  MAUDE report 22956617 ↗
• InjuryAug 27, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PROSTHESIS WEAR OF THE POLYETHYLENE LINER. AS A RESULT, APPROXIMATELY TWELVE YEARS AND TEN MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION TO REPLACE THE POLYETHYLENE LINER. DURING THE REVISION SURGERY IT WAS NOTED THAT THE PATELLAR IMPLANT HAS SOME WEAR, BUT THE SURGEON CHOSE NOT TO REPLACE IT. 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: Insufficient Information

  MAUDE report 22908122 ↗
• InjuryAug 1, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS AND 2 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE POLY INSERT AND PATELLA WERE REVISED FOR FAILURE OF THE COMPONENTS AND WEAR. THE INSERT HAD DELAMINATED AND CRACKED. SEVERAL PIECES WERE RECOVERED. THE IMPLANTS WERE REPLACED WITH VIT E IMPLANTS. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 22686872 ↗
• InjuryJul 31, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 124 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. FINDINGS INDICATED WEAR OF THE PATELLA AND TIBIAL POLYETHYLENE INSERT, A LOOSE TIBIAL COMPONENT, AND TIBIAL BONE LOSS. THE SURGEON PERFORMED A REVISION RIGHT TOTAL KNEE ARTHROPLASTY USING A COMPETITOR¿S DEVICES. PATIENT WAS AWAKENED, EXTUBATED, AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. HE TOLERATED THE PROCEDURE WELL AND THERE WERE NO KNOW COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Osteolysis; Pain

  MAUDE report 22681775 ↗
• InjuryJul 28, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY EIGHT YEARS POST INITIAL LEFT TKA, THE 74 Y/O MALE PATIENT COMPLAINED OF PAIN AND HAD A RECALLED POLY. PATIENT HAD A POLY SWAP. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY AND IMAGE RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE RECALL DEVICES.

  Patient problems: Pain

  MAUDE report 22630281 ↗
• InjuryJul 10, 2025Naturally Worn; Naturally Worn

  REVISION WAS DONE BASED ON FEMUR BEING LOOSE. WAS REVISED TO A DEPUY REVISION KNEE. REVISION WAS DONE BY DEPUY..REP WAS AT HOSPITAL AND TOLD A REVISION WAS BEING DONE AND EXACTECH IMPLANTS WERE BEING REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Cyst(s); Joint effusion; Osteolysis

  MAUDE report 22467289 ↗
• InjuryJun 2, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLYETHELENE WEAR AND FEMORAL LOOSENING, AS A RESULT OF OSTEOLYSIS. THE PATIENT WAS REVISED TO A SIZE 4 FEMORAL COMPONENT AND A SIZE 4 TIBIAL INSERT. THERE WAS BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED AT HOSPITAL.

  Patient problems: Osteolysis

  MAUDE report 22126455 ↗
• InjuryMay 14, 2025Naturally Worn; Naturally Worn

  EXPERIENCE REPORT USA. PATIENT ID: (B)(6). IT WAS REPORTED APPROXIMATELY 115 MONTHS AFTER A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A PLANNED RIGHT KNEE REVISION PROCEDURE TO ADDRESS SIGNIFICANT PROSTHESIS WEAR. IT WAS REPORTED THE SURGEON OBSERVED BREAKAGE OF A DEVICE(S) AND FRAGMENTS; PARTS OR PIECES FELL INTO THE PATIENT. IT WAS REPORTED ALL THE FRAGMENTS AND PIECES WERE REMOVED AND RETRIEVED FROM THE PATIENT AND PATIENT WOUND SITE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. THE PATIENT WAS REVISED TO AN EXACTECH INSERT AND A COMPETITOR'S PATELLA. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS OF THE EXPLANTED INSERT AND PATELLA WERE PROVIDED. NO MEDICAL REPORTS OR OPERATIVE REPORTS WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. 4079529 200-02-38 THREE PEG PATELLA 38MM IS AFFECTED BY RECALL # 1038671-04/18/2024-002-R.

  Patient problems: Insufficient Information

  MAUDE report 22022620 ↗
• InjuryMay 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 3 YEARS POST OP. THE PATIENT WAS REVISED DUE TO FEMUR LOOSENING CAUSED BY OSTEOLYSIS FROM TIBIA POLY AND PATELLA WEAR. ALL COMPONENTS WERE REMOVED AND REVISED BY OTHER COMPANY¿S REVISION KNEE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISPOSED AT HOSPITAL.

  Patient problems: Osteolysis

  MAUDE report 22008966 ↗
• InjuryMay 13, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS AND 11 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PATELLA AND TIBIAL BEARING WEAR. 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. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22008470 ↗
• InjuryApr 23, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 9.5 YEARS POST INITIAL RIGHT TKA, THE 65 Y/O MALE PATIENT HAD POLY VISIBLY WORN ON X-RAYS. PATIENT HAS SWOLLEN AND PAINFUL KNEE. POLY WAS IDENTIFIED AS NON-CONFORM DURING THE RECALL PROCESS AND REVISION WAS SCHEDULED TO CHANGE POLY. THE POLY WAS SHOWING SIGNIFICANT SIGNS OF WEAR ON THE ARTICULATING SURFACE AND THE POSTERIOR FACE OF THE PEG. THE LINER HAD THINNED VERY SIGNIFICANTLY ON THE MEDIAL SIDE, ABOUT 4/5 MM COMPARED TO ITS ORIGINAL THICKNESS. PATELLA HAS SIGNS OF WEAR TOO, WITH EVIDENCE OF OSTEOLYSIS BEHIND THE POLY. THERE WERE LOT OF FIBROUS TISSUES INSIDE THE JOINT WHICH WAS REMOVED. THIS WAS CONSISTENT TO WHAT CAN BE FOUND WHEN SIGNIFICANT POLY WEAR TAKES PLACE. PATIENT'S TIBIAL TRAY WAS KEPT. NEW POLY WAS INSERTED (15MM), PATELLA WAS REMOVED AND NEW PATELLA WAS CEMENTED (SAME SIZE, 38MM). THERE WAS NO BREAKAGE OF DEVICE AND NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE KEPT BY THE HOSPITAL. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT. SEE MDR#1038671-2023-00578.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21895937 ↗
• InjuryApr 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 4 YEARS POST INITIAL OPERATION. SUBSEQUENTLY, THE PATIENT PRESENTED TO SURGEON WITH A LOOSE TIBIA AND PATELLA. SURGEON REMOVED A 38 PATELLA, A SIZE 4F/3T TIBIAL TRAY AND A 14 X 25 TIBIAL STEM. ALSO THE LINER WAS A SIZE 4/13MM CONSTRAINED PS INSERT. THE SURGEON REVISED TO A THE TIBIA TO A 4F/3T WITH A 16 X 80 STEM. THE PATELLA WAS REVISED TO A 41MM THREE PEG PATELLA. A 32 TIBIAL METAPHYSEAL CONE AND A. 4/19MM CONSTRAINED INSERT. THE PATIENT IS EXTREMELY ACTIVE AND DOES MANUAL LABOR FOR WORK. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; Joint Laxity; Loss of Range of Motion

  MAUDE report 21864786 ↗
• InjuryApr 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY MONTHS AFTER A RIGHT KNEE REPLACEMENT SURGERY. THE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS PROSTHESIS WEAR AND PAIN. FEMUR AND PATELLA COMPONENTS WERE INDICATED TO BE LOOSE. NO SURGICAL OR MEDICAL INTERVENTIONS WERE RECORDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 21767710 ↗
• InjuryApr 1, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS POST OP INITIAL LEFT TKA, THIS 69 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - CHAIN OF COMMAND. DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Discomfort; Pain; Swelling/ Edema

  MAUDE report 21742034 ↗
• InjuryMar 26, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 03JUN2024. AS REPORTED IN LEGAL EMAIL RECEIVED 03JUN2024 "PER THE ATTORNEY, MR. (B)(6) PATELLAR FRACTURE WAS DIRECTLY RELATED TO THE RECALLED IMPLANT BECAUSE THERE WAS SIGNIFICANT OSTEOLYSIS (BONE LOSS) SURROUNDING THE FRAGMENTED PATELLAR COMPONENT...PLEASE SEE XRAY ATTACHED FOR DOS (B)(6) 2022". (NO XRAYS ARE ATTACHED IN EMAIL DATED 03JUN2024.). INITIAL CONSULT VISIT NOTE DATED (B)(6) 2024 AND PROGRESS NOTE DATED (B)(6) 2022 ARE ATTACHED. ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 02-NOV-2023. LEGAL CASE ¿ USA. PATIENT ID: (B)(6) LK. RELATED (B)(4) RK. IMPLANT DATE: (B)(6) 2015, DR. (B)(6). EXPLANT DATE: (B)(6) 2022, DR. (B)(6), OP REPORT ATTACHED. ORIGINAL DESCRIPTION SUMMARY: ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 29-SEP-2023. LEGAL CASE ¿ USA (MDL NO. (B)(4)). PATIENT ID: (B)(6) LK REV. RELATED (B)(4) RK REV. 8. PLAINTIFF WAS IMPLANTED WITH THE FOLLOWING EXACTECH DEVICE: OPTETRAK LOGIC. 9. LEG IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: LEFT. 10. DATE THE EXACTECH DEVICE WAS IMPLANTED: (B)(6) 2015. 11. STATE IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: (B)(6). 12. DATE THE EXACTECH DEVICE WAS SURGICALLY REMOVED/REVISED: (B)

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint effusion; Muscle Weakness/Atrophy; Osteolysis; Pain; Synovitis

  MAUDE report 21702090 ↗
• InjuryMar 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 7 YEARS 2 MONTHS POST INITIAL OPERATION. SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MILD OSTEOLYSIS WAS PRESENT. PATELLA EXHIBITED MILD WEAR ALONG LATERAL TRACKING PATH. TIBIAL INSERT HAD MILD WEAR MEDIALLY AND POSTERIOR TO POST. FEMORAL AND TIBIAL COMPONENT WERE WELL FIXED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 21632334 ↗
• InjuryMar 14, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 107 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN. 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: Pain

  MAUDE report 21607494 ↗

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-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-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-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