Optetrak 200-07-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862314291), received between Jan 9, 2024 and Aug 10, 2026 — classified as 13 injuries.

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

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

3 other recalls cover devices cleared under the same FDA submission (K160484); 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-2158-2024 · 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Naturally Worn

  It was reported that the patient underwent an initial left total knee arthroplasty. Subsequently, it was reported that the patient experienced pain, swelling and prosthesis wear. As a result, the patient underwent a left knee revision approximately 1 year and 6 months after initial implantation. During the revision it was noted that the femoral component was loose. The patient was transferred to the recovery room in stable condition. No further information available.

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

  MAUDE report 50189477 ↗
• InjuryDec 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REPORT 2 OF 2: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, 3 MONTHS POST-OPERATIVE, THE PATIENT EXPERIENCED A DISLOCATION WITH PROGRESSIVE LATERAL PATELLAR SUBLUXATION AND WAS PRESCRIBED A MCL BRACE AND PHYSICAL THERAPY. IT WAS LATER REPORTED THAT THE PATIENT IS STILL EXPERIENCING THE DISLOCATION AND SUBLUXATION. AS A RESULT, APPROXIMATELY 1 YEAR AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT OPEN LATERAL RETINACULAR RELEASE SURGERY. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Subluxation

  MAUDE report 23704096 ↗
• InjuryAug 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 71 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS SWELLING AND RECALLED POLYETHYLENE. THE PATIENT DID EXTREMELY WELL FOLLOWING THE SURGERY BUT DEVELOPED INCREASED SWELLING IN THE POSTEROMEDIAL ASPECT OF THE KNEE APPROXIMATELY 6 MONTHS PRIOR TO REVISION. PATIENT WAS NOT HAVING ANY PAIN, BUT THE SWELLING INTERFERED WITH HIS ACTIVITIES. A PRE-OPERATIVE MRI SHOWED SIGNIFICANT SYNOVITIS WITH COMMUNICATION OF A POSTEROMEDIAL CYST WITHIN THE JOINT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. FINDINGS CONFIRMED SIGNIFICANT SYNOVITIS WITH POLYETHYLENE DEBRIS AND SCAR TISSUE AROUND THE PATELLAR BUTTON. THERE WAS ALSO SIGNIFICANT DAMAGE WITH GOUGING OF THE MEDIAL AND LATERAL FACET AND FLATTENING OF THE LATERAL FACET OF THE PATELLA, WHICH WAS REPLACED. IN INSPECTION, THERE WAS NO SIGNIFICANT WEAR OF THE TIBIAL INSERT, BUT THERE WAS SIGNIFICANT LAXITY OF THE KNEE IN FLEXION AND EXTENSION. THIS WAS RESOLVED BY UPSIZING FROM A 13MM POSTERIOR STABILIZED TO 15MM POSTERIOR STABILIZED CONSTRAINED TIBIAL POLYETHYLENE. MUCH OF THE SWELLING WAS THE INFLAMED TISSUE FROM THE CYST, WHICH WAS REMOVED. THE PAT

  Patient problems: Cyst(s); Joint Laxity; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 22844896 ↗
• InjuryMay 28, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 78 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS FEMORAL LOOSENING. THE PATIENT EXPERIENCED JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, POLYETHYLENE WEAR, OSTEOLYSIS, AND INTACT CEMENT MANTLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. X-RAY AND DEVICE PHOTO PROVIDED. NO DEVICE RETURNS ANTICIPATED. DUE TO THE RECALL, THE HOSPITAL WILL NOT RELEASE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Osteolysis; Swelling/ Edema

  MAUDE report 22096956 ↗
• InjuryMay 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 69 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PERSISTENT AND INCREASING SIZE OF THE EFFUSION WITH WEIGHTBEARING PAIN. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PREOPERATIVE DIAGNOSIS: 1. FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR. POSTOPERATIVE DIAGNOSIS: 1. FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR. 2. ASEPTIC LOOSE FEMORAL COMPONENT. THE PATIENT IS A 61-YEAR-OLD GENTLEMAN WHO IS A FEW YEARS STATUS POST PRIMARY LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. HE HAS HAD PERSISTENT AND INCREASING SIZE OF THE EFFUSION RECENTLY WITH WEIGHTBEARING PAIN. INFECTION WORKUP HAS BEEN NEGATIVE. HE IS IN THE EXACTECH RECALL AND WAS FELT TO REPRESENT POLYETHYLENE WEAR AND OSTEOLYTIC DEBRIS. DESCRIPTION OF PROCEDURE: THERE WAS SYNOVITIS. SUBTOTAL SYNOVECTOMY WAS PERFORMED. THE PATELLA WAS EVERTED AND FOUND TO BE OXIDATED AND DELAMINATED. IT WAS THEN RESECTED JUST BENEATH THE CEMENT FOR A RESIDUAL THICKNESS OF 15MM. PREVIOUS 12 INSERT WAS REMOVED. FEMORAL COMPONENT WAS TESTED AT THIS POINT WITH A RETROGRADE DISIMPACTION AND EASILY POPPED OFF

  Patient problems: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 22044559 ↗
• InjuryMar 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 74 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN (B)(6) 2017, WAS REVISED IN (B)(6) 2025, APPROXIMATELY 7 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN, THEY HAD A RECALLED PATELLA AND INSERT. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY IMAGES WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. CHAIN OF COMMAND, DUE TO THE RECALL THE HOSPITAL WILL NOT RELEASE THEM. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 21548077 ↗
• InjuryMar 3, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 44 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, IMPLANT PAIN, JOINT EFFUSION, AND OSTEOLYSIS. INITIAL SURGERY AND 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: Implant Pain; Joint effusion; Osteolysis

  MAUDE report 21510056 ↗
• InjuryFeb 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 52 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, PAIN, SCAR TISSUE, SWELLING/EDEMA, AND SYNOVITIS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21414277 ↗
• InjuryNov 12, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 2 MONTHS POST INITIAL LEFT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT WAS REVISED TO A COMPETITOR PROSTHESIS DUE TO COMPLAINTS OF PAIN, LOOSE FEMUR, AND RECALLED INSERT AND PATELLA. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 20669074 ↗
• InjurySep 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 69 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PERSISTENT AND INCREASING SIZE OF THE EFFUSION WITH WEIGHTBEARING PAIN; OSTEOLYTIC DEBRIS, OXIDATED AND DELAMINATED PATELLA, ASEPTIC LOOSE FEMORAL. 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: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20168357 ↗
• InjuryJul 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY 40 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR PROSTHESIS WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19827505 ↗
• InjuryJul 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 77 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS EFFUSIONS, PAIN, AND LOOSENING. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Osteolysis; Pain

  MAUDE report 19724431 ↗
• InjuryJan 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  STUDY: (B)(6) CLINICAL STUDY. SUBJECT: (B)(6). AS REPORTED BY THE (B)(6) CLINICAL STUDY, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2018 AND PRESENTED ON (B)(6) 2018 WITH DISLOCATION - PROGRESSIVE LATERAL PATELLAR SUBLUXATION REPORTED ABOUT 3 MONTHS AGO POST-OP AND CONTINUED DESPITE PHYSICAL THERAPY AND BRACING. OPEN LATERAL RETINACULAR RELEASE WAS PERFORMED ON (B)(6) 2018 FOR PATELLAR SUBLUXATION LEFT TOTAL KNEE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNKNOWN TO BE RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. MCL BRACE, PT AND OPEN LATERAL RETINACULAR RELEASE SURGERY (B)(6) 2018. THE OUTCOME OF THIS EVENT IS RESOLVED ON (B)(6) 2018. HEIGHT: 69 IN. DIAGNOSIS: OSTEOARTHRITIS. COMORBIDITIES: HYPERTENSION, INSULIN DEPENDENT DIABETES MELLITUS, CELIAC DISEASE, SLEEP APNEA, CHRONIC BACK PAIN, GERD, PERIPHERAL NEUROPATHY, SSS/PACEMAKER, BPH. 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT: (B)(6). 510K: K160484. CONCOMITANTS: 02-022-35-4015 - TRULIANT TIB IMP PS INSERT SZ 4 15MM: (B)(6). SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K152170. 02-020-11-0240 - TRULIANT PS CEM FEM PS CEM LEFT SZ 4: (B)(6). 02-022-45-

  Patient problems: Failure of Implant; Subluxation

  MAUDE report 18481148 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160484. 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-2155-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;