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BEAR Implant (Bridge-Enhanced ACL Restoration) 1000Recalls & reported problems

Miach Orthopaedics, Inc. · Resorbable implant for anterior cruciate ligament (ACL) repair. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL. · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Miach BEAR implant is a resorbable implant used to repair a torn ACL. Among 29 reports, many provide too little information or describe no apparent issue; detailed reports mention unusual implant consistency or hydration, ongoing pain, allergic reaction, and the ACL not healing as expected. There were no deaths, 5 injuries, and 24 malfunctions. There are 2 open recalls, including one for an incorrect expiration date and UDI; reports fell from 24 to 4.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
29
Deaths reported
0
Injuries reported
5
Recalls naming it
2

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00860002987804), received between Oct 16, 2024 and Mar 12, 2026 — classified as 5 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 22 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202622
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Dec 31, 2025Class IIOpen, Classified

    Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.

    Z-1220-2026 · Root cause: Process control · Recall details · FDA record ↗

  2. Feb 2, 2023Class IIOpen, Classified

    The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

    Z-0479-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • No Apparent Adverse Event22
  • Adverse Event Without Identified Device or Use Problem5
  • Use of Device Problem2
  • Device Handling Problem1

Patient problems

  • Insufficient Information22
  • Limb Pain2
  • Wound Infection2
  • Ambulation or Postural Difficulties1
  • Arthritis1
  • Blister1
  • Cartilage damage1
  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

    PATIENT STATES: I HAD AN ACL REPAIR WITH BEAR IMPLANT AND HAD SEVERE ALLERGIC REACTION THAT REQUIRED A LOA AND A REMOVAL OF ACL.DATE OF SURGERY NOT PROVIDED.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 24576920 ↗
  • MalfunctionJan 9, 2026No Apparent Adverse Event

    IMPLANT WOULD NOT HYDRATE. SURGEON SATURATED THE IMPLANT IN NEARLY 20CC OF BLOOD, AND AFTER A FEW MINUTES, THE SURGEON WENT BACK IN AND PULLED OUT THE IMPLANT. IT WAS STILL REALLY FIRM.

    Patient problems: Insufficient Information

    MAUDE report 24027288 ↗
  • MalfunctionDec 11, 2025Use of Device Problem; Use of Device Problem

    PATIENT STATED: "IT'S IMPORTANT TO INFORM (B)(6) AND MIACH THAT I HAD SIGNIFICANT PAIN FOLLOWING THE SURGERY. THE SURGEON DECIDED TO INCLUDE A CHONDROPLASTY AND MENISCUS SURGERY WHILE REPAIRING MY ACL. AFTER SURGERY, I HAVE HAD CONSTANT PAIN AND IT'S STILL BOTHERING ME TODAY. I WAS UNABLE TO WALK UP AND DOWN STAIRS WITHOUT SIGNIFICANT PAIN FOR OVER A YEAR AND A HALF." AND "I ALSO HAVE A BUMP THAT APPEARED IMMEDIATELY AFTER SURGERY ON MY RIGHT KNEE THAT LOOKS LIKE OSGOOD SCHLATTER DISEASE. THE BUMP WAS NOT PRESENT BEFORE SURGERY. I ASKED THE SURGEON ABOUT THE BUMP AND HE SAID IT WAS FROM SWELLING. IT'S STILL PRESENT ON MY KNEE AND PROTRUDES EVEN MORE SINCE THE SWELLING HAS SUBSIDED. MY RIGHT KNEE CONTINUES POPPING, CRACKING AND CATCHING."

    Patient problems: Limb Pain

    MAUDE report 23782779 ↗
  • InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT EMAILED THE CUSTOMER SERVICE TEAM ON (B)(6) 2025 TO "ASKING FOR A RESOLUTION/GUIDANCE FOR MY BEAR IMPLANT CASE". IN (B)(6) 2022 THE PATIENT TORE THEIR RIGHT KNEE ACL AND MENISCUS. THE PATIENT TRAVELED FROM (B)(6) TEXAS, WHERE THE ORTHOPAEDIC SURGEON PERFORMED THE ACL BEAR IMPLANT PROCEDURE AND ALSO REPAIRED THEIR MENISCUS ON (B)(6) 2022. 11 MONTHS POST-SURGERY, THE PATIENT REPORTED THAT MY KNEE HAD NOT IMPROVED. AT THAT TIME, HE WAS RECOMMENDED TO GET AN MRI. IN (B)(6) 2023, THE PATIENT UNDERWENT A SECOND SURGERY AND RESUMED PHYSICAL THERAPY IMMEDIATELY AFTERWARD. THE PATIENT CLAIMS THAT THEY WERE INFORMED THAT THE BEAR IMPLANT HAD NOT BEEN ENTIRELY SUCCESSFUL AND HAD CAUSED SECONDARY DAMAGE TO MY CARTILAGE, LEADING TO THE DEVELOPMENT OF ARTHRITIS. THE PATIENT VISITED A SURGEON IN MAYO CLINIC, SPORT CENTER. THEY PERFORMED AN EXTENSIVE EVALUATION OF THEIR KNEE.. AN MRI AND X-RAYS REVEALED THAT MY BEAR ACL IMPLANT HAD NEARLY FAILED, WITH ONLY THE IMPLANT'S STRINGS STILL HOLDING IT IN PLACE. THIS HAS ALSO CAUSED THE PCL TO BUCKLE. FURTHERMORE, THEY FOUND SIGNIFICANT DAMAGE TO MY KNEE CARTILAGE, NOTING THAT THE PATIENT HAD LOST NEARLY 20% OF MY CARTILAGE COMPARED TO THEIR HEALT

    Patient problems: Arthritis; Cartilage damage; Limb Pain

    MAUDE report 23607598 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    DR'S CASE ON MONDAY HE HAD A COMPLAINT REGARDING HOW RAPIDLY THE IMPLANT TOOK ON BLOOD, BECOMING MUSH IN ONLY A FEW SECONDS. HE ASKED IF I COULD MENTION SOMETHING TO QUALITY CONTROL AS HE HAS NOT SEEN AN IMPLANT ABSORB BLOOD THIS QUICKLY THUS FAR IN HIS EXPERIENCE WITH BEAR. THE IMPLANT WAS STILL IMPLANTED LIKE NORMAL, AND THE DR WAS CONFIDENT THE GRAFT MADE IT WHERE IT WAS SUPPOSED TO.

    Patient problems: Insufficient Information

    MAUDE report 22965625 ↗
  • MalfunctionSep 4, 2025Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

    THE BEAR PATIENT'S MOM EMAILED MIACH INDICATING THAT THE BEAR SURGERY DID NOT TREAT/FIX HER DAUGHTER'S ACL. HER DAUGHTER HAD AN 9 MO MRI AND THE ACL LOOKED TORN. (B)(6) CALLED THE PATIENT'S MOM ON (B)(6) 2024 BASED ON THE EMAIL SHE HAD SENT MIACH WHEN THE MOM NOTIFIED THAT SHE THINKS THE ACL WAS NOT REGROWN WITH THE BEAR IMPLANT. SHE SAID THE DAUGHTER DID NOT HAVE AN INJURY, JUST A TWIST TO HER KNEE THEN SHE STARTED FEELING THAT IT WAS UNSTABLE. (B)(6) ALSO SPOKE WITH THE DR. ON (B)(6) 2024 TO UNDERSTAND IF THERE WAS ANYTHING OUT OF THE ORDINARY DURING THE SURGERY. DR. INDICATED THE PATIENT WAS SLOW MOVING DURING THE INITIAL PART OF REHAB AND THE ONLY THING DURING SURGERY THAT WAS OUT OF THE ORDINARY WAS THAT HE ADDED BMAC AND PRP TO THE KNEE AT THE END OF THE SURGERY BECAUSE THE PATIENT ALSO HAD A MENISCUS TEAR THAT HE TREATED.

    Patient problems: Ambulation or Postural Difficulties

    MAUDE report 22965619 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    A BEAR IMPLANT FROM LOT: 7009361 CAME OUT OF THE PACKAGING LOOKING AND FEELING DIFFERENT. ACCORDING TO THE DR. THE IMPLANT WAS VERY SOFF COMPARED TO PREVIOUS DEVICES AND SHE WAS ABLE TO SQUEEZE IT. SHE HAS DONE ALMOST 30 CASES SO SHE ELECTED TO DISCARD THE DEVICE AND USE ANOTHER. THE IMPLANT WAS THROWN IN THE TRASH AND IS NOT AVAILABLE FOR EVALUATION. THE CASE WAS COMPLETED SUCCESSFULLY WITH SECOND IMPLANT. PATIENT IS DOING WELL.

    Patient problems: Insufficient Information

    MAUDE report 22965580 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    DRS CASE ON MONDAY HE HAD A COMPLAINT REGARDING HOW RAPIDLY THE IMPLANT TOOK ON BLOOD, BECOMING MUSH IN ONLY A FEW SECONDS. HE ASKED IF I COULD MENTION SOMETHING TO QUALITY CONTROL AS HE HAS NOT SEEN AN IMPLANT ABSORB BLOOD THIS QUICKLY THUS FAR IN HIS EXPERIENCE WITH BEAR. THE IMPLANT WAS SUCCESSFULLY IMPLANTED INTO THE PATIENT AND THE PROCEDURAL OUTCOME WAS FINE.

    Patient problems: Insufficient Information

    MAUDE report 22965578 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    THE BEAR IMPLANT HAD ALMOST NO GRADIENT AND IT WAS VERY DIFFICULT TO TELL WHICH SIDE WAS DENSER. THE IMPLANT DID NOT WANT TO HYDRATE. I'VE SEEN OVER 200 BEAR IMPLANTS GO IN, AND DOCTOR HAS DONE 25, SO I'M GOING TO SUGGEST NO USER ERROR HERE. HE USED 15 CC OF BLOOD, AND THE CORE WAS STILL ROCK HARD, ADDITIONALLY, UPON IMPLANTING, A FEW CHUNKS BROKE OFF FROM THE DISTAL END. I ASKED HIM AT THE END OF THE CASE HOW IT FELT, AND HE SAID WHAT WAS IN THE NOTCH WAS GOOD. THE CASE WAS COMPLETED SUCCESSFULLY WITH THE IMPLANT. PATIENT IS DOING WELL.

    Patient problems: Insufficient Information

    MAUDE report 22965576 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    THE BEAR IMPLANT DID NOT HYDRATE PROPERLY AND IN FACT, NOT REALLY AT ALL. WE HYDRATED THE DEVICE WITH 15CC WHOLE BLOOD, THEN LET THE TOURNIQUET DOWN TO FILL UP THE SPECIMEN CUP WITH ANOTHER 20+ CC OF BLOOD. AFTER ABOUT 5 MINUTES OF WAITING FOR THE IMPLANT TO HYDRATE, DR. ATTEMPTED TO PASS THE DEVICE THROUGH THE ARTHROTOMY AND THE IMPLANT BROKE IN HALF VERTICALLY. HE TOOK ONE OF THE HALVES AND SUBMERGED IT IN THE SPECIMEN CUP OF BLOOD AND IT STILL DIDN'T GET ANY SOFTER. WE OPENED A SECOND IMPLANT FROM A DIFFERENT LOT, AND IT HYDRATED IMMEDIATELY SO WE WERE ABLE TO FINISH THE PROCEDURE, BUT DR. SAID THAT WHAT WAS LEFT OF THE FIRST IMPLANT WAS STILL VERY FIRM INSIDE THE KNEE WHEN HE CLOSED (THE KNEE). PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SECOND IMPLANT. PATIENT IS DOING WELL.

    Patient problems: Insufficient Information

    MAUDE report 22965575 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    EARLIER THIS WEEK, WE HAD AN IMPLANT DISINTEGRATE. I ASKED THE DOCTOR TO EXPLAIN IN HIS WORDS AND HE SAID, IT DISINTEGRATED - THERE WAS HARDLY ANYTHING LEFT. NO CLOT. NOTHING. I SUGGESTED WE OPEN ANOTHER IMPLANT AND THIS ONE DID NOT WANT TO HYDRATE. SAME LOT, SAME TECHNIQUE. WHEN HE WENT TO IMPLANT, A CHUNK OF THE IMPLANT BROKE OFF. THE CASE WAS COMPLETED WITH A SECOND IMPLANT.

    Patient problems: Insufficient Information

    MAUDE report 22965573 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    BEAR IMPLANT HYDRATED ]VERY FAST (~ 30 SECONDS) AND FELL APART WHILE HYDRATING. OPENED A SECOND IMPLANT, WHICH HYDRATED MUCH BETTER. IMPLANTED SECOND IMPLANT FROM THE SAME LOT WITHOUT ISSUES.

    Patient problems: Insufficient Information

    MAUDE report 22964830 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    THE IMPLANT HYDRATED VERY QUICKLY WITH ONLY 5 CC OF BLOOD APPLIED, AT WHICH POINT THE DEVICE FELL OFF THE INTERNAL BRACE SUTURES PRIOR TO IMPLANTATION. THE DEVICE REMAINED IN THE SURGEON'S HAND, SO HE IMPLANTED THE DEVICE, BUT IT WAS NOT LOADED ON THE SUTURES. HE THEN BACKFILLED WITH 5 CC OF BLOOD. THE TOTAL TIME FROM THE FIRST DROP OF BLOOD UNTIL THE IMPLANT FELL OFF THE SUTURES WAS APPROXIMATELY 1:30. IN MY OPINION AND IN SPEAKING TO THE DR ABOUT THE CASE AFTERWARDS, HE PROBABLY OVERMANIPULATED THE IMPLANT AND RUSHED TO HYDRATE WITH BLOOD (HE WAS BULLETING THE TIP AND MASSAGING THE SIDES). HOWEVER, HE COULD NOT HAVE IMPLANTED THE DEVICE SOONER BECAUSE HE WAS STILL WORKING BLOOD INTO THE DEVICE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SAME DEVICE. PATIENT IS DOING WELL.

    Patient problems: Insufficient Information

    MAUDE report 22964802 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    THE FIRST IMPLANT WE UTILIZED ALMOST IMMEDIATELY HYDRATED AND THE SURGEON'S FINGER WENT THROUGH THE AXIS OF THE IMPLANT WHEN PUSHING INTO THE NOTCH AND COULD NOT BE IMPLANTED. QUICK HYDRATION CAUGHT US ALL OFF GUARD. CASE WAS COMPLETED SUCCESSFULLY WITH A SECOND DEVICE (LOT 7009359).

    Patient problems: Insufficient Information

    MAUDE report 22964801 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REP REPORTED THAT THE BEAR IMPLANT HYDRATED QUICKLY (< 20 SECONDS) AND INCONSISTENTLY. VISUALLY, THE DEVICE APPEARED HIGHLY VARIABLE FROM TOP (PROXIMAL) END OF IMPLANT TO THE BOTTOM (DISTAL) END. WHEN HYDRATED, BLOOD RAN THROUGH THE DEVICE AND WAS COMING OUT OF THE SUTURE HOLES. THE BOTTOM OF THE IMPLANT ALSO HYDRATED QUICKLY. DEVICE WAS VERY MALLEABLE IN THE ARTHROTOMY. THE DEVICE DID NOT HYDRATE CONSISTENTLY AND THE BOTTOM (DISTAL) END CAME OFF IN THE KNEE; HOWEVER, DR WAS ABLE TO PUSH THIS PORTION BACK ONTO THE IMPLANT PRIOR TO CLOSING THE KNEE.

    Patient problems: Insufficient Information

    MAUDE report 22964796 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    REP REPORTED THAT THE BEAR IMPLANT HYDRATED QUICKLY'(< 15 SECONDS) AND FELL APART IN DR'S HANDS PRIOR TO INSERTION INTO THE KNEE. REP STATED THAT DR WAS MANIPULATING THE BLOOD INTO THE IMPLANT AGGRESSIVELY BECAUSE THE IMPLANT TOOK QUITE A LONG TIME TO HYDRATE IN A PREVIOUS CASE. A SECOND DEVICE FROM THE SAME LOT WAS OPENED AND IT HYDRATED ADEQUATELY AND WAS IMPLANTED.

    Patient problems: Insufficient Information

    MAUDE report 22964791 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    (B)(4) DISTRIBUTOR REPORTED THE EVENT. THE BEAR IMPLANT BECAME OVERHYDRATED WITH THE PATIENT'S BLOOD AND TURNED TO MUSH. MOST, IF NOT ALL, OF THE IMPLANT WAS UNABLE TO BE INSERTED INTO THE PATIENT'S KNEE. THIS WAS A PROXIMAL TEAR. THE SURGEON WAS COMFORTABLE WITH A PRIMARY REPAIR WITHOUT BEAR AND CHOSE NOT TO OPEN AND HYDRATE ANOTHER BEAR IMPLANT. VERY MINIMAL TIME DELAY (2-3 MINUTES) AND NO ADVERSE PATIENT CONSEQUENCES EXPECTED. HYDRATION TOOK APPROXIMATELY 3 - 4 MINUTES.

    Patient problems: Insufficient Information

    MAUDE report 22964778 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    IMPLANT LOOKED A LITTLE OFF FROM THE START. COULDN'T DIFFERENTIATE POROUS AND DENSE SIDE. BOTH LOOKED A LITTLE ROUGH AND THERE WASN'T A FLAT STRAIGHT SURFACE VISIBLE LIKE WE NORMALLY SEE ON THE DENSE SIDE. SURGEON PASSED TWO SUTURE TAPE TAILS THROUGH THE IMPLANT, BOTH TOWARDS THE MIDDLE OF THE IMPLANT. WHEN WE WENT TO HYDRATE, WE HYDRATED THE TOP HALF OF THE IMPLANT AND IT HYDRATED WITHIN 20 SECONDS. WHEN THE SURGEON BEGAN TO SLIDE IT TOWARDS THE KNEE, IT COMPLETELY FELL OFF OF THE SUTURES OUTSIDE OF THE KNEE. WE OPENED A NEW IMPLANT AND PASSED THE CINCH SUTURES THROUGH IT AND IT HYDRATED MUCH MORE NORMALLY AND IMPLANTED NORMALLY.

    Patient problems: Insufficient Information

    MAUDE report 22964747 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    BEAR IMPLANT HYDRATED IN 15 SECONDS AND FELL APART. IMPLANT WAS DISCARDED AND PROCEDURE WAS COMPLETED WITH A SECOND IMPLANT. SECOND IMPLANT WORKED AS EXPECTED AND WAS FROM THE SAME LOT.

    Patient problems: Insufficient Information

    MAUDE report 22964136 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    WHEN OPENED FROM POUCH, IT WAS DIFFICULT TO DISCERN TOP OF IMPLANT FROM BOTTOM (BASE). BEAR IMPLANT HYDRATED] VERY FAST AND FELL APART WHEN ATTEMPTING TO PUT IN KNEE. IMPLANT WAS DISCARDED AND PROCEDURE WAS COMPLETED WITH A SECOND IMPLANT. SECOND IMPLANT LOOKED BETTER AND HYDRATED NORMALLY AND WAS FROM THE SAME LOT.

    Patient problems: Insufficient Information

    MAUDE report 22964133 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    THE DEVICE LOOKED NORMAL WITH NO DEFECTS WHEN REMOVED FROM THE PACKAGE. A SMALL SECTION OF THE BASE OF THE IMPLANT DID NOT ABSORB BLOOD COMPLETELY (IT REMAINED FIRM AND DID NOT SOFTEN) AND BROKE OFF FROM THE REST OF THE IMPLANT WHILE THE KNEE WAS BEING CLOSED. SIZE OF THE SECTION WAS APPROXIMATELY 0.5" X 0.5". A TOTAL OF 12 ML OF BLOOD WERE APPLIED TO THE IMPLANT, WITH APPROXIMATELY 3-4 ML RUNOFF. DR WAS NOT CONCERNED WITH THE PATIENT OR EVENT. PROCEDURE WAS COMPLETED AS NORMAL.

    Patient problems: Insufficient Information

    MAUDE report 22964132 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    WHEN OPENED FROM POUCH, IT WAS DIFFICULT TO DISCERN TOP OF IMPLANT FROM BOTTOM (BASE). BEAR IMPLANT HYDRATED VERY FAST AND FELL APART WHEN ATTEMPTING TO PUT IN KNEE. IMPLANT WAS DISCARDED AND PROCEDURE WAS COMPLETED WITH A SECOND IMPLANT. SECOND IMPLANT LOOKED BETTER AND HYDRATED NORMALLY AND WAS FROM THE SAME LOT.

    Patient problems: Insufficient Information

    MAUDE report 22964131 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    ON MONDAY WE HAD AN INCIDENT WHERE WE HAD TO WRITE OFF AN IMPLANT (7009363) DUE TO IT HYDRATING FAR TOO QUICKLY (<10 SECONDS) AND BECOMING UNABLE TO PROPERLY IMPLANT. THE SECOND IMPLANT OF THE SAME LOT HYDRATED IN AN APPROPRIATE AMOUNT OF TIME. THE CASE WAS COMPLETED WITH A SECOND IMPLANT.

    Patient problems: Insufficient Information

    MAUDE report 22937508 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    IMPLANT HYDRATED EXTREMELY SLOW. TOOK 20 CC AND MAYBE 5 MIN. MUCH MUCH MUCH SLOWER THAN AVERAGE HYDRATION. COULD TELL THE IMPLANT WAS VERY DENSE WHEN SURGEON SLID KEITH NEEDLE INTO IT. SURGEON USED A SYRINGE MULTIPLE TIMES TO INJECT BLOOD INTO THE CORE OF THE IMPLANT. WE WERE STILL ABLE TO USE IT AND IT SOFTENED UP AFTER ABOUT FIVE MINUTES OF HYDRATING WHEN THE IMPLANT WAS ALREADY IN THE KNEE. THE CASE WAS COMPLETED SUCCESSFULLY WITH THE IMPLANT. PATIENT IS DOING WELL.

    Patient problems: Insufficient Information

    MAUDE report 22936922 ↗
  • MalfunctionSep 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

    DR. WAS DISAPPOINTED BY THE DENSITY OF THE BEAR. IT WAS TOO DENSE AND DID NOT SEEM TO HAVE A POROUS SIDE. THIS HAPPENED WITH TWO OF THE IMPLANTS USED ON (B)(6) 2023. HOWEVER, THESE WERE OF THE SAME LOT AS THE ONE USED ON (B)(6) 2023. HE IS CONCERNED ABOUT THE VARIABILITY BETWEEN IMPLANTS OF THE SAME LOT AND DOES NOT LIKE THE DIFFICULTY HE HAD HYDRATING IT. THIS IS THE FIRST TIME HE HAS HAD TO USE THE BLUNT TIPPED NEEDLE TO PROPERLY HYDRATE THE BEAR. DR. SPECIFICALLY TOLD ME TO MAKE A NOTE OF IT AND DID WAS NOT THRILLED BY THE SITUATION. PATIENT RECEIVED BEAR IMPLANT AND IS DOING FINE.

    Patient problems: Insufficient Information

    MAUDE report 22936889 ↗

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