MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 58MM GROUP 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	180-01-58
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Related- mfr#1038671-2021-00141 report 1 of 2.H11.Additional manufacturer narrative.Report 2 of 2.D10.Sn (b)(6) , cat# 130-32-53 nv gxl lnr, neutral, 32mm id, group 3 cups.These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.
Event or Problem Description
It was reported via legal documentation that a patient received an initial total right hip arthroplasty and then approximately 8 years, 2 months later was revised on (b)(6) 2023 for ¿considerable wear¿ and the implant had loosened the socket with advanced granulosteolysis.The patient then received subsequent treatment from (b)(6) 2023 from a rehabilitation clinic.The patient had been scheduled for revision surgery in 2021, but this was postponed due to covid.No other information is available.
Additional Manufacturer Narrative
Additional information: h3: the revision reported may have been the result of acetabular loosening and prosthesis wear.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the implant and the bone.The prosthesis wear could include a number of variables including use error, implant positioning, implant size selection, and patient factors.Additionally, increased shelf oxidation resulting from the use of nylon vacuum bags without evoh could also have contributed to the wear.However, this cannot be confirmed as the devices were not available for evaluation and no images or radiographs were provided.H6: component code, investigation codes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2021-00141.The revision reported may have been the result of acetabular loosening and prosthesis wear.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the implant and the bone.The prosthesis wear may be due to a combination of the risk factors such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).Additionally, a contributing factor to the wear may have been the off-label use detailed above.However, this cannot be confirmed because the devices were not available for evaluation, and no images or radiographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to correct the following field that was entered erroneously in the initial report: g3: aware date 15-mar-2021.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV CROWN CUP CLSTR HOLE 58MM GROUP 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19745754
• Report Number: 1038671-2024-02394
• Device Sequence Number: 8875296
• Product Code: JDI
• UDI-Device Identifier: 10885862037046
• UDI-Public: 10885862037046
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2017
• Device Catalogue Number: 180-01-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/18/2024; 10/18/2024; 03/26/2025
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 10/22/2024; 02/26/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male