CONTROLRecalls & reported problems across all models

We found 5 models of CONTROL by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2018 and Jun 15, 2026 — classified as 54 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CONTROL problems

CONTROL models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CONTROL 1739-28-000

  CERCLAGE, FIXATION
  52 reports
• CONTROL 2739-40-000

  CUTTER, WIRE
  2 reports
• CONTROL 1738-30-000

  Wire, surgical
  1 report
• CONTROL 1739-18-000

  CERCLAGE, FIXATION
  1 report
• CONTROL 2739-10-000

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent CONTROL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY, SLEEVE, AND STEM AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION POST REVISION TKA. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED UTILIZING LPS COMPONENTS WITH HIGH DOSE ANTIBIOTICS AND RESORBABLE ANTIBIOTIC BEADS. SIGNIFICANT BONE LOSS WAS NOTED ON THE TIBIA AS THE INFECTION APPEARED TO HAVE BEEN PRESENT FOR SOME TIME BUT WAS UNTREATED UNTIL PATIENT SHOWED UP IN THE ER. NO DELAY OR PATIENT HARM WAS NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25503650 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WOUND BREAKDOWN POST MULTIPLE REVISION TKA LEADING TO POTENTIAL CONTAMINATION OF THEIR PROSTHESES. THE SURGEON CHOSE TO REMOVAL ALL WELL FIXED AND WELL FUNCTIONING COMPONENTS AND PLACE A STATIC SPACER FASHIONED WITH LPS COMPONENTS WITHOUT DELAY NOR PATIENT HARM. A GASTROC FLAP WAS PERFORMED BY THE PLASTIC SURGEON POST SPACER PLACEMENT IN HOPES OF HEALING THIS WOUND. THIS PATIENT HAS HAD MULTIPLE SURGERIES SINCE THIS DATE TO ADDRESS COMPLICATIONS WITH IMPLANTS BEING EXCHANGED. THE DATES WERE AND THE DER NUMBERS ARE LISTED 3-6-2026 601633, 3-26-2026 603113 4-8-2026 604361. DOI: ON (B)(6) 2026, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 25187266 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HEMATOMA POST REVISION TKA. SURGEON PERFORMED AN EVACUATION OF HEMATOMA WITH A THOROUGH I&D AND COMPONENT EXCHANGE. ALL COMPONENTS WERE WELL FUNCTIONING SO NO ALLEGATION WAS MADE AGAINST ANY COMPONENT, HOWEVER CHOSE TO EXCHANGE MODULAR COMPONENTS AS THE RISK FOR INFECTION IS ELEVATED IN THIS CIRCUMSTANCE. CABLE WAS ALSO REMOVED AS IT COULD HARBOR BACTERIA IF INFECTION IS FOUND TO BE PRESENT ON CULTURES. CULTURES WERE TAKEN AS A PRECAUTION AND RESORBABLE ANTIBIOTIC BEADS WERE PLACED. NO DELAY OR PATIENT HARM WAS NOTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 24731664 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN LPS DISTAL FEMORAL REPLACEMENT REVISION TKA PLACED ON (B)(6) 2025. HE PRESENTED WITH A DRAINING KNEE AND WAS BROUGHT TO THE OR FOR A ONE STAGE REVISION UTILIZING A DUAL SET UP. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED SO NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. CEMENT WAS DEPUY 2 WITH GENT, HOWEVER IS HOSPITAL OWNED SO NO QTY OR LOT INFORMATION IS AVAILABLE. BOTH TIBIAL AND PATELLAR COMPONENTS WERE WELL FIXED VIA CEMENT SO NO ALLEGATION IS MADE AGAINST THE CEMENT. WHILE WELL FIXED, NO INGROWTH WAS FOUND ON EITHER SLEEVE, FURTHER CONFIRMING INFECTION. A THOROUGH IRRIGATION AND DEBRIDEMENT WAS PERFORMED AFTER ALL COMPONENTS WERE REMOVED. NEW COMPONENTS WERE PREPARED FOR. NEW COMPONENTS WERE OPENED ON A "CLEAN" TABLE AND IMPLANTED AFTER NEW DRAPES AND STAFF CHANGING INTO "CLEAN" GOWNS AND GLOVES WAS COMPLETED. ALL NEW COMPONENTS WERE PLACED ALONG WITH RESORBABLE ANTIBIOTIC BEADS AND ANTIBIOTIC CEMENT. NO DELAY NOR PATIENT HARM WAS NOTED. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24266981 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTS WITH INFECTION POST SPACER. HOWEVER, PATIENT NOW PRESENTS WITH A FUNGAL INFECTION. ALL COMPONENTS PERFORMED AS EXPECTED AND WERE WELL FIXED, HOWEVER HAD TO BE REMOVED TO TREAT THIS NEW FINDING. ALL COMPONENTS WERE SUCCESSFULLY REMOVED, AND AFTER A THOROUGH DEBRIDEMENT, THE BONE WAS PREPARED FOR NEW COMPONENTS. DURING DEBRIDEMENT, A VESSEL WAS PERFORATED DUE TO SCAR TISSUE AND WAS REPAIRED OPERATIVELY. THE SURGEON STATED THIS TO BE A COMMON OCCURRENCE DUE TO THE LOCATION OF DEBRIDEMENT ANATOMICALLY AND WAS EXPECTED AND PREPARED FOR. THIS RESULTED IN A SHORT DELAY WHILE THE REPAIR TOOK PLACE. NEW COMPONENTS WERE PLACED UNEVENTFULLY FOR A NEW SPACER, ALONG WITH PLACEMENT OF ANTIBIOTIC BEADS, ANTIFUNGAL BEADS AND HIGH DOSE ANTIBIOTIC CEMENT. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 24162381 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND SURGEON ELECTED TO REMOVE IMPLANTS AND FUSE KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23369928 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT NOT LOOSE, JUST NOT INGROWN. NOT THE SAME THING.

  Patient problems: Unspecified Infection

  MAUDE report 22872284 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FAILED RIGHT TOTAL HIP ARTHROPLASTY FROM RECALLED ACETABULAR IMPLANT. PATIENT WAS EXPERIENCING WORSENING PAIN AND CALCAR WAS IMPACTED THERE WAS NOTED TO BE A CRACK. SIGNIFICANT METALLIC STAINING OF THE SYNOVIAL LAYER. EVIDENCE OF TRUNNION CORROSION. DOI: (B)(6) 2007, DOR: (B)(6) 2023, AFFECTED SITE: RIGHT HIP,

  Patient problems: Foreign Body Reaction; Necrosis; Pain

  MAUDE report 22787205 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ASPIRATED LAST WEEK AND IS NOW GROWING YEAST. ALL COMPONENTS WERE REMOVED IN A ONE STAGE REVISION AND NEW COMPONENTS WERE PLACED AFTER A THOROUGH I&D AND PLACEMENT OF RESORBABLE BEADS CONTAINING ANTIBIOTICS AND AN ANTIFUNGAL AGENT. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED HOWEVER THE FEMORAL SLEEVE HAD FAILED TO INGROW, LIKELY DUE TO THE FUNGUS BEING PRESENT. TIBIAL COMPONENT AND CEMENTED STEM WERE PLACED ON THE ABOVE LISTED DATE. FEMORAL COMPONENTS AND INSERT HAD BEEN REVISED ON (B)(6) 2025 FOR CONTINUED INFECTION. A DER WAS FILED UNDER (B)(4) PER OPTIMIZE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22748177 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: CAN YOU PROVIDE ANY INFORMATION REGARDING WHEN THE INFECTION BEGAN AND IF THERE WERE ANY PREVIOUS DEPUY PRODUCTS THAT HAVE BEEN REVISED AND/OR REPORTED. LATE ON (B)(6) 2025. PATIENT HAD BILATERAL DEPUY KNEE REPLACEMENTS IN WHEN HE WAS ADMITTED WITH SEPSIS. HE HAD BOTH SHOULDER, NATIVE, AND BOTH KNEES INFECTED AT THAT TIME.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 22688922 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUED TO DRAIN FROM KNEE WOUND. SURGEON ELECTED TO REMOVE KNEE PROSTHESIS AND FUSE THE KNEE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22336438 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUED TO DRAIN FROM KNEE WOUND. SURGEON ELECTED TO REMOVE KNEE PROSTHESIS AND FUSE THE KNEE. THIS COMPLAINT (B)(4) IS RELATED TO (B)(4). DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22329255 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY OPERATED ON FOR AN INFECTED NON-UNION OF FUSION. SINCE CULTURES WERE NEGATIVE, SURGEON CHOSE TO REIMPLANT THE PATIENT. CONTINUED DRAINAGE SUGGESTS INFECTION. SINCE THE PATIENT CONTINUES TO DRAIN DESPITE NEGATIVE CULTURES, THE SURGEON CHOSE TO REMOVE ALL COMPONENTS AND CONVERT TO A STATIC SPACER UTILIZING LPS COMPONENTS, PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND HIGH DOSE ANTIBIOTIC CEMENT TO COAT THE COMPONENTS. ALL COMPONENTS WERE WELL FIXED BUT LACK OF BONY INGROWTH ALSO SUGGESTS PERSISTENT INFECTION. AN I&D WAS PERFORMED ON (B)(6) 2025, WHERE THE POLY AND PIN WERE REPLACED. DEPUY 2 WITH GENTAMICIN WAS LIKELY UTILIZED, AS THAT IS THE SURGEON'S NORM. NO DELAY OCCURRED AND NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22214716 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO SHOW SIGNS OF INFECTION AND WAS BROUGHT TO THE OR FOR BILATERAL KNEE REVISIONS. COMPONENTS WERE REMOVED AND THOROUGH I&DS WERE PERFORMED IN CONJUNCTION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS, AND PLACEMENT OF NEW COMPONENTS. PATIENT DID HAVE BILATERAL I&DS WITH POLY EXCHANGES ON (B)(6) 2025. AS SUCH, THE INSERTS LISTED ON THIS SUBMISSION WERE FROM THAT DATE. THE RIGHT KNEE SHOWED SIGNIFICANT HETEROTOPIC OSSIFICATION AROUND THE FEMORAL SLEEVE, SUGGESTING INFECTION ON XRAY, SO SURGEON TO CHOSE TO FASHION A STATIC SPACER UTILIZING LPS COMPONENTS TO TREAT THIS SIDE. THE LEFT SIDE APPEARED TO BE DOING BETTER, BUT SINCE HOSPITAL ADMISSION EARLIER THIS WEEK ALSO BEGIN TO SWELL. WHEN CHECKING FIXATION OF THE FEMORAL COMPONENT, THE FEMORAL SLEEVE WAS ABLE TO BE REMOVED WITHOUT SIGNS OF BONY INGROWTH. LACK OF INGROWTH APPROXIMATELY SEVEN (7) WEEKS POST IMPLANTATION SUGGESTS THIS TOO WAS INFECTED. TIBIAL COMPONENT AND STEM WERE LEFT IN PLACE ON THE LEFT SIDE SINCE IT WAS WELL FIXED. NO DELAY NOR PATIENT HARM WAS NOTED. WHILE RESULTS ARE NOT YET AVAILABLE, SURGEON DOES BELIEVE INFECTION WAS STILL PRESENT AT THE TIME OF THIS PROCEDURE. THIS INFEC

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 22179304 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO SHOW SIGNS OF INFECTION AND WAS BROUGHT TO THE OR FOR BILATERAL KNEE REVISIONS. COMPONENTS WERE REMOVED AND THOROUGH I&DS WERE PERFORMED IN CONJUNCTION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS, AND PLACEMENT OF NEW COMPONENTS. PATIENT DID HAVE BILATERAL I&DS WITH POLY EXCHANGES ON (B)(6) 2025. AS SUCH, THE INSERTS LISTED ON THIS SUBMISSION WERE FROM THAT DATE. THE RIGHT KNEE SHOWED SIGNIFICANT HETEROTOPIC OSSIFICATION AROUND THE FEMORAL SLEEVE, SUGGESTING INFECTION ON XRAY, SO SURGEON TO CHOSE TO FASHION A STATIC SPACER UTILIZING LPS COMPONENTS TO TREAT THIS SIDE. THE LEFT SIDE APPEARED TO BE DOING BETTER, BUT SINCE HOSPITAL ADMISSION EARLIER THIS WEEK ALSO BEGIN TO SWELL. WHEN CHECKING FIXATION OF THE FEMORAL COMPONENT, THE FEMORAL SLEEVE WAS ABLE TO BE REMOVED WITHOUT SIGNS OF BONY INGROWTH. LACK OF INGROWTH APPROXIMATELY SEVEN (7) WEEKS POST IMPLANTATION SUGGESTS THIS TOO WAS INFECTED. TIBIAL COMPONENT AND STEM WERE LEFT IN PLACE ON THE LEFT SIDE SINCE IT WAS WELL FIXED. NO DELAY NOR PATIENT HARM WAS NOTED. WHILE RESULTS ARE NOT YET AVAILABLE, SURGEON DOES BELIEVE INFECTION WAS STILL PRESENT AT THE TIME OF THIS PROCEDURE. THIS INFEC

  Patient problems: Extraskeletal ossification; Unspecified Infection

  MAUDE report 22159197 ↗

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