Novation 180-01-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862037015), received between Feb 12, 2020 and Jun 9, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 reports).

16 other recalls cover devices cleared under the same FDA submission (K070479); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Peeled/Delaminated

  IT WAS REPORTED THAT A PATIENT, WHO HAD A LEFT THA, PRESENTED WITH COMPLAINTS OF PAIN AND UNDERWENT A REVISION PROCEDURE. THE REPORT STATED THE COATING CAME OFF OF THE CUP. THE LINER AND CROWN CUP WERE REVISED. 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 ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO CHAIN OF COMMAND. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 25451517 ↗
• InjuryMay 14, 2026Migration

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT A LEFT HIP REPLACEMENT. THE PATIENT LATER RETURNED TO THE PHYSICIAN¿S OFFICE WITH COMPLAINTS OF PAIN, STIFFNESS, DECREASED RANGE OF MOTION, INSTABILITY, AND DISSATISFACTION RELATED TO THEIR LEFT TOTAL HIP ARTHROPLASTY (THA). EVALUATION REVEALED THE PRESENCE OF A RECALLED GXL LINER, A MALPOSITIONED ACETABULAR CUP, ASSOCIATED BONE LOSS, AND FEMORAL COMPONENT LOOSENING. ALSO, PHOTOGRAPHS PROVIDED SHOW WEAR ON THE LINER. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY. THE PROCEDURE INVOLVED EXPLANTATION OF ALL EXISTING HIP COMPONENTS. DUE TO THE EXTENT OF BONE LOSS, ADDITIONAL BONE GRAFT SUBSTITUTE WAS REQUIRED. A REVISION LOCKING ACETABULAR CUP WAS IMPLANTED WITH A NEW ACETABULAR LINER, AND THE FEMORAL COMPONENT WAS REVISED WITH PLACEMENT OF A MONOBLOCK REVISION STEM. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Unspecified Musculoskeletal problem

  MAUDE report 25174587 ↗
• InjuryJan 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 71 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Implant Pain; Pain; Scar Tissue

  MAUDE report 21265987 ↗
• InjuryJan 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 14 YEARS AND 7 MONTHS POST THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO THE CUP LOOSENING, CAUSING PAIN. THE PATIENT WAS REVISED TO A COMPETITOR CUP. 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: Pain

  MAUDE report 21252199 ↗
• InjuryNov 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY AND THEN APPROXIMATELY 129 MONTHS LATER EXPERIENCED A REVISION SURGERY. FAILED RIGHT THA (ACETABULAR IMPLANTS). SEVERE POLY WEAR WITH SOFT TISSUE DAMAGE AROUND THE HIP JOINT. FEMORAL STEM WAS STABLE AND WELL FIXED ¿ THEREFORE DID NOT REVISE. CUP WAS EASILY REMOVED ¿ IT WAS NOT WELL FIXED. THE BACKSIDE OF THE CUP HAD NO BONE IN-GROWTH. THERE WAS EXTENSIVE SOFT TISSUE DEBRIS THROUGHOUT THE KNEED JOINT CONSISTENT WITH SYNOVITIS FROM A POLYETHYLENE REACTION TO THE TISSUES. THIS WAS TINY, SMALL BALLS OF LIGHT BROWN SYNOVIUM ALONG WITH A ¿PSEUDO-CAPSULE¿ OF DENSE SOFT TISSUE RIND. EXAMINATION OF POLYETHYLENE ¿ EXCESSIVE WEAR WAS PRESENT WITH SIGNS OF OXIDATION / YELLOW DISCOLORATION, PITTING, CRACKING AND DELAMINATION OF THE POLY. SEVERE ECCENTRIC SUPERIOR LATERAL POLY WEAR. PATIENT REVERSED FROM ANESTHESIA AND SENT TO PACU IN STABLE CONDITION. 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 OTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Synovitis

  MAUDE report 20774973 ↗
• InjuryOct 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 92 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS, OSTEOLYSIS. 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1732-2022.

  Patient problems: Implant Pain; Osteolysis; Synovitis

  MAUDE report 20391116 ↗
• InjurySep 9, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, SEVERE PAIN; SEVERE OSTEOLYSIS, SIGNIFICANT POLYETHYLENE WEAR, CUP HAD MINIMAL FIXATION TO BONE. 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 Laxity; Osteolysis; Pain

  MAUDE report 20169481 ↗
• InjurySep 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN, POLYETHYLENE WEAR, AND DISLOCATION. WEAR WAS NOTED ON THE X-RAY, BUT IT WAS NOT CONFIRMED IN THE CASE REPORT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Distress; Implant Pain; Joint Dislocation; Osteolysis

  MAUDE report 20145950 ↗
• InjuryAug 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S LEFT HIP WAS REVISED 8 YEARS POST OP. THE PATIENT HAD HIP PROSTHETIC CUPS FROM EXACTECH IMPLANTED ON THE RIGHT (CERAMIC INLAY) IN 2013 AND ON THE LEFT (PE INLAY) IN 2015. DUE TO INCREASING LOAD-RELATED COMPLAINTS ON THE LEFT SIDE, SHE CAME TO OUR OUTPATIENT CLINIC FOR A CHECK-UP. THE X-RAY AND CT SCAN SHOWED A CLEAR DECENTRATION OF THE PROSTHETIC HEAD AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED DURING THE PROSTHETIC REVISION. UNFORTUNATELY, THE CUP WAS NO LONGER FIRMLY INTEGRATED, SO THAT, IN ADDITION TO THE KERATECTOMY AND FILLING OF THE CYSTS WITH ALLOGENEIC CANCELLOUS BONE, A CHANGE TO A CUP ANCHORED WITH 3 SCREWS WAS CARRIED OUT. IN ADDITION, THE PROSTHESIS HEAD WASCHANGED.

  Patient problems: Osteolysis

  MAUDE report 19919705 ↗
• InjuryNov 8, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REVISION ON(B)(6) 2019. APPROXIMATELY 11 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND LEFT HIP REVISION ON (B)(6) 2020. 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. REVISION OP REPORT (B)(6) 2020: DIAGNOSIS: FAILED LEFT THA. THERE WAS A TROCHANTERIC BURSITIS AND A BURSECTOMY WAS PERFORMED. THE ACETABULAR COMPONENT WAS LOOSE. THE ALLOGRAFT BONE WAS MORE FLAKY AND NOT BLEEDING.

  Patient problems: Failure of Implant; Joint effusion

  MAUDE report 18093889 ↗
• InjuryMay 31, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Unstable; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  REVISION OPERATIVE REPORT OF (B)(6) 2020: POSTOPERATIVE DIAGNOSIS- FAILED RIGHT TOTAL HIP REPLACEMENT DUE TO INSTABILITY WITH DISLOCATION- ACETABULAR REVISION. REVISED TO NON EXACTECH ALL POLY CONSTRAINED CUP. STEM STABLE AND WELL FIXED. POLYETHYLENE LINER FROM THE NON EXACTECH CUP. IMPLANTED: NON EXACTECH ALL POLY CONSTRAINED CUP /22MM +0 COBALT CHROME HEAD FOR EXACTECH STEM.

  Patient problems: Implant Pain; Insufficient Information; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17034551 ↗
• InjuryOct 14, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) YEAR OLD FEMALE PATIENT HAD A P-SERIES STEM WITH NOVATION CUP INSERTED ON AN UNKNOWN DATE, A LTK IMPLANTED APPROXIMATELY 10 YEARS AGO IN VIRGINIA. THE PATIENT EXPERIENCED ON GOING PAIN BEFORE CUP BECAME LOOSE AND SPUN OUT OF POSITION. P-SERIES STEM WAS RETAINED AND A NEW HEAD WAS PLACED ON THE WELL FIXED STEM. CUP WAS CHANGED TO A ZIMMER ACETABULAR CAGE COMPONENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE DEVICE WAS DISPOSED BY HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 12637106 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, PATIENT WAS BEING REVISED DUE TO PAIN AND SIGNIFICANT OSTEOLYSIS. PROPHYLACTIC POSTERIOR COLUMN PLATING AND THEN REMOVED THE NOVATION CUP AND GXL LINER.

  Patient problems: Osteolysis

  MAUDE report 11805288 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH HIP REPLACEMENT STUDY, DURING THE FEMORAL PREPARATION A CALCAR FRACTURE WAS IDENTIFIED, AND A PROTECTIVE CERCLAGE WAS USED. THE EVENT IS NOT RELATED TO THE DEVICE BUT RELATED TO THE PROCEDURE. THIS EVENT WAS RECEIVED FROM THE HIP CLINICAL STUDY DATA.

  Patient problems: Bone Fracture(s)

  MAUDE report 9699856 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070479. One submission often covers many models, so check the product and lot details in each record.

• Z-1729-2022 · Aug 11, 2022 · Open, Classified
  GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRA
• Z-2127-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant
• Z-2123-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40
• Z-2131-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Line
• Z-2121-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID;
• Z-2116-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28m
• Z-2128-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant
• Z-2117-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral,
• Z-2133-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant,
• Z-2118-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral,
• Z-2132-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL a
• Z-2120-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant
• Z-2126-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner,
• Z-2122-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped A
• Z-0787-2013 · Nov 5, 2012 · Terminated
  Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replaceme

…and 1 more.