Novation 130-28-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10885862022066), received between Oct 25, 2019 and May 12, 2025 — classified as 27 injuries.

The most frequently reported specific device problem is “Naturally Worn” (22 reports).

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

14 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.

Recalls naming this device

1. Aug 11, 2022Class IIOpen, Classified

   Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

   Z-1729-2022 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 29, 2021Class IIOpen, Classified

   Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

   Z-2116-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT HIP IMPLANTED IN (B)(6) 2010, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2018, APPROXIMATELY 8 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. REASON FOR THE REVISION UNKNOWN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22005677 ↗
• InjuryOct 14, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 106 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. 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-1729-2022.

  Patient problems: Insufficient Information

  MAUDE report 20439430 ↗
• InjuryOct 11, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. (B)(4)): (B)(4) IS ASSOCIATED WITH THIS CASE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4), AND PENDING IN THE EASTERN DISTRICT OF (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE. UNABLE TO CONFIRM SPECIFIC DEVICES DUE TO BILATERAL EBI INVOICE DATA. THE SERIAL NUMBER (B)(6) ARE CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1729-2022. 130-28-51 - NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS; SERIAL: (B)(6); 510K: K070479; UDI: (B)(4); PRODUCT CODE: JDI, LPH, LWJ, LZO, MEH; X-RAY: NO; OPERATIVE NOTES: NO. CONCOMITANT DEVICES: (B)(6), 186-01-48 - INTEGRIP CC, CLUSTER 48MM, G1; (B)(6), 186-01-50 - INTEGR

  Patient problems: Ambulation or Postural Difficulties; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20431197 ↗
• InjuryOct 11, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). (B)(4) LH IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 52 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, AMBULATORY PROBLEMS, JOINT PAIN AND WEAKNESS, OSTEOLYSIS, PAST AND FUTURE MEDICAL EXPENSES, PAST AND FUTURE LOST WAGES, LOSS OF EARNING CAPACITY, MENTAL SUFFERING AND ANGUISH, PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. UNABLE TO CONFIRM SPECIFIC DEVICES DUE TO BILATERAL EBI INVOICE DATA. THE SERIAL NUMBER (B)(6) ARE CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1729-2022.

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

  MAUDE report 20430707 ↗
• InjurySep 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 98 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 20245953 ↗
• InjurySep 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 71 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND OSTEOLYSIS. 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: Osteolysis; Pain; Scar Tissue

  MAUDE report 20200338 ↗
• InjurySep 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 168 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20170027 ↗
• InjurySep 3, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE - USA. THIS PATIENT IS VERIFIED LEFT HIP ON (B)(6) 2015 AT (B)(6) HOSPITAL. SHE HAD LEFT HIP REVISION (B)(6) 2023 WITH DR (B)(6 . PLEASE REVIEW THE ATTACHED REVISION OP REPORT AND CONFIRM THIS IS WITHIN THE SCOPE OF THE RECALL.

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

  MAUDE report 20131377 ↗
• InjuryJun 19, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 114 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567292 ↗
• InjuryJun 3, 2024Unstable; Detachment of Device or Device Component; Naturally Worn; Unstable; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 55 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING AND STIFFNESS, LOSS OF FUNCTION, TISSUE DAMAGE, REVISION SURGERY, INSTABILITY, AND POLYETHYLENE LINER DISSOCIATION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 19446271 ↗
• InjuryMay 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 65 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, OSTEOLYTIC BONE LOSS, OSTEOLYTIC CHANGE, AND RECALLED POLYETHYLENE. 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; Failure of Implant; Implant Pain; Osteolysis; Pain

  MAUDE report 19366730 ↗
• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 7 YEARS 3 MONTHS POST THE INITIAL THA, THE 77 YEAR OLD FEMALE PATIENT WAS REVISED DUE TO ABNORMAL WEAR AND A RECALLED POLY. 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: Failure of Implant; Insufficient Information

  MAUDE report 19341643 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 59 YO FEMALE PATIENT, INITIAL LEFT HIP IMPLANTED ON (B)(6) 2013, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 10 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH PAIN. THE HIP AND LINER WERE REVISED TO A 32 BIOLOX DELTA HEAD, A 10 DEGREE LINER, AND A BIOLOX + 0 ADAPTER 12/14. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE STABLE FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS AS THE HOSPITAL WILL NOT RELEASE THEM. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 18833802 ↗
• InjuryFeb 21, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY NINE YEARS POST INITIAL LEFT TKA, THE FEMALE PATIENT WAS REVISED DUE TO A FAILED LINER. A REVISION SURGERY WAS PERFORMED DUE TO LINER WEAR AND OSTEOLYSIS. ALL COMPONENTS WERE REMOVED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION WAS REPORTED. SALES REP WAS UNABLE TO OBTAIN PHOTO/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO THEY WERE DISPOSED AT HOSPITAL.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18750135 ↗
• InjuryFeb 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2020 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 3 YEARS AND 3 MONTHS AFTER INITIAL IMPLANT. REVISION OP REPORT STATED THAT THE POLYETHYLENE LINER HAD SIGNIFICANT CATASTROPHIC WEAR. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18722947 ↗
• InjuryNov 16, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT THA, THE SURGEON REVISED AN EXACTECH HIP. THE SURGEON REMOVED THE INTEGRIP CLUSTER-HOLE SHELL, NOVATION CROWN CUP GXL LINER AND BIOLOXDELTA FEMORAL HEAD. THE SURGEON WAS REPLACED WITH A COMPETITOR'S CUP/LINER AND AN EXACTECH BIOLOX OPTION FEMORAL HEAD WITH BIOLOX OPTION ADAPTER. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS OR PHOTOS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION (LEGAL CASE).

  Patient problems: Failure of Implant; Joint Dislocation; Osteolysis

  MAUDE report 18148377 ↗
• InjuryJul 24, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION -APPROXIMATELY 6 WEEKS OUT FOLLOWING A LEFT PRIMARY HIP REPLACEMENT WHO WAS DOING WELL UNTIL SHE FAINTED AND PASSED OUT AT HOME AND DISLOCATED HER HIP. THIS WAS REDUCED IN THE ER, HOWEVER, 5 DAYS LATER SHE WAS GETTING UP FROM A SEATED POSITION AND FELT IT DISLOCATE AGAIN AND WAS REDUCED IN THE ER THAT NIGHT. IT DISLOCATED A THIRD TIME /PATIENT WAS SEEN FOR REVISION. AT THE TIME OF THE CLOSED REDUCTION, SHE WAS UNSTABLE IN FLEXION AND INTERNAL ROTATION. THERE IS NO OPERATIVE DISPOSITION NOTED IN THE OPERATIVE REPORT. THERE IS NO MENTION OF DEVICE MALFUNCTION OR WEAR IN THE OPERATIVE REPORT. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: Fall; Hematoma; Joint Dislocation

  MAUDE report 17377779 ↗
• InjuryJun 2, 2023Mechanical Problem; Naturally Worn; Insufficient Device Problem Information; Mechanical Problem; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2017 AND THEN APPROXIMATELY 5 YEARS, 7 MONTHS LATER, ON (B)(6) 2022, THE PATIENT EXPERIENCED A REVISION SURGERY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Insufficient Information; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 17053399 ↗
• InjuryMay 15, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 5 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2021 DUE TO PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PATIENT'S MOBILITY AND QUALITY OF LIFE AND NECESSITATED A REVISION SURGERY AND THE RESULTANT PAIN FOLLOWING SURGERY AND RECUPERATION/REHABILITATION PERIOD AND PHYSICAL THERAPY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Failure of Implant; Implant Pain; Muscle Weakness/Atrophy

  MAUDE report 16929147 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  LEGAL CASE (B)(6). AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT IS AN 80 YEAR OLD FEMALE WITH A VERIFIED RIGHT HIP ON (B)(6) 2013. SHE HAD A RIGHT HIP REVISION ON (B)(6) 2022, APPROXIMATELY 8 YEARS AND 4 MONTHS AFTER THEIR INITIAL SURGERY. POSTOP DIAGNOSIS: RIGHT HIP OSTEOLYSIS AFTER PREVIOUS TOTAL HIP ARTHROPLASTY. REVISED TO EXACTECH NOVATION XLE. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL #: (B)(4), CATEGORY #: 130-28-51 - NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS, SERIAL NUMBER (B)(4) , IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K070479. CONCOMITANTS: SERIAL #: (B)(4) , CATEGORY #: 150-23-00 - MODULAR XTRA SMALL META 23MM, SERIAL #: (B)(4), CATEGORY #: 150-07-16 - MODULAR STRAIGHT STEM 13MM X 165MM, SERIAL #: (B)(4) , CATEGORY #: 158-02-06 - 12/14 LPB M-SERIES NECK LOW OFFSET +0, SERIAL #: (B)(4) , CATEGORY #: 142-28-03 - COCR FEM HEAD 28MM +3.5

  Patient problems: Cyst(s); Osteolysis; Pain

  MAUDE report 16717352 ↗
• InjuryAug 30, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL FILING, THAT A FEMALE PATIENT WHO HAD A RIGHT THA ON OR ABOUT (B)(6) 2013, BEGAN FEELING PAIN AND DISCOMFORT AND RETURNED TO HER ORTHOPEDIST. ON (B)(6) 2016, A CT SCAN REVEALED ¿SOME LINER WEAR WITHIN THE ACETABULUM¿ AND ¿EVIDENCE OF OSTEOLYSIS ALONG THE SUPERIOR ASPECT OF THE ACETABULUM.¿. THE PAIN PROGRESSED AND RECORDS REFLECT THAT BY (B)(6) 2017 THE PAIN EVOLVED TO THE POINT WHERE THE PATIENT WAS IN SO MUCH PAIN THAT SHE WAS NOT ¿ABLE TO GO TO WORK OR SLEEP.¿ ON OR ABOUT (B)(6) 2017, APPROXIMATELY 4 YEARS 1 MONTH POST THE INITIAL PROCEDURE, THE PLAINTIFF UNDERWENT PAINFUL AND RISKY RIGHT TOTAL HIP REPLACEMENT REVISION SURGERY TO REMOVE THE DEFECTIVE GXL LINER DUE TO ¿ECCENTRIC POLY[ETHYLENE] WEAR.¿ HER GXL LINER AND FEMORAL HEAD WERE REMOVED AND SHE WAS IMPLANTED WITH A NEW NOVATION CROWN CUP SIZE 28 NEUTRAL CONNEXION GXL LINER AND SIZE 28 MM +0 FEMORAL HEAD.

  Patient problems: Pain

  MAUDE report 15325080 ↗
• InjuryAug 30, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL FILING, THAT A FEMALE PATIENT WHO HAD UNDERWENT A REVISION OF HER RIGHT THA ON (B)(6) 2017, SUFFERED A DISLOCATION OF HER RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2017. SHE WAS TREATED WITH A CLOSED REDUCTION ON OR ABOUT (B)(6) 2017. DUE TO RIGHT GROIN PAIN AT REST AND WITH ACTIVITY, SHE RETURNED TO HER ORTHOPEDIC SURGEON FOR EVALUATION. ON OR ABOUT (B)(6) 2021, X-RAYS SHOWED ¿ABNORMAL SUPERIOR WEAR OF [HER] POLYETHYLENE¿ LINER AND ¿EVIDENCE OF OSTEOLYSIS IN THE ISCHIUM AND ILIUM.¿ HER IMPLANTING ORTHOPEDIST DETERMINED SHE WOULD NEED REVISION SURGERY GIVEN THE ¿EXTENSIVE POLYETHYLENE WEAR AND OSTEOLYSIS.¿ REPEAT X-RAYS ON OR ABOUT (B)(6) 2021, REVEALED AN ALMOST COMPLETELY WORN-OUT LINER AND SIGNIFICANT OSTEOLYSIS BEHIND THE CUP.¿ ON OR ABOUT (B)(6) 2021, HER IMPLANTING ORTHOPEDIST OBSERVED HER (B)(6) 2021 CT SCAN DEMONSTRATED ¿EXTENSIVE OSTEOLYSIS WITH SIGNIFICANT DESTRUCTION OF THE POSTERIOR COLUMN¿ AND AGAIN DISCUSSED REVISION SURGERY THOUGH ¿BECAUSE OF THE HISTORY OF 2 SUCCESSIVE FAILURES OF THE POLYETHYLENE WITHIN 4 YEARS,¿ HER IMPLANTING ORTHOPEDIST INDICATED HE ¿WOULD NEED TO BE SATISFIED THAT CHANGES HAVE BEEN MADE AND THE QUALITY OF THE POLYETHYLEN

  Patient problems: Pain

  MAUDE report 15324966 ↗
• InjuryAug 10, 2022Naturally Worn; Naturally Worn

  THE 73 YEAR OLD FEMALE PATIENT INVOLVED WAS REPORTED FOR REVISIONS DUE TO EARLY PROSTHESIS WEAR AND SUBSEQUENT OSTEOLYSIS APPROXIMATELY 5.5 AND 4.5 YEARS AFTER THE RESPECTIVE INDEX THA SURGERIES. THE PROSTHESIS WEAR WAS ABLE TO BE CONFIRMED FROM THE PROVIDED RADIOGRAPHS. HOWEVER, THE EXPLANTED DEVICES WERE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 15205076 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 7 YEARS POSTOP THE INITIAL R THA, THE (B)(6) PATIENT PRESENTED WITH A GROSSLY UNSTABLE R HIP. SURGEON BELIEVES IT WAS BECAUSE OF SIGNIFICANT POLY WEAR. THE PATIENT RECEIVED AN XLE VERSION OF THE SAME POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL NOT RETURN DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12701400 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS FEMALE PATIENT IS 8 YRS POSTOP THE INITIAL RTHA. POLY WIRE OUT IN 4 YEARS REQUIRING EXCHANGE IN 4 YRS AGO. SHE¿ NOW HAS RIGHT RIGHT GROIN PAIN AND OSTEOLYSIS. MAY NEED TO REVISE HER ENTIRE CUP. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Osteolysis

  MAUDE report 12616909 ↗

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-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-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-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-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-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-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-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-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-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-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-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-0788-2013 · Nov 5, 2012 · Terminated
  Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip r
• 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