MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 52MM GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	180-01-52
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): 180-01-52, ln: 10143151 - nv crown cup clstr hole 52mm group 2].No cn, ln: 71343204 - femoral head.
Event or Problem Description
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 was changed.
Additional Manufacturer Narrative
The revision reported was likely 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 specified in an hhe, including edge loading.Additionally, a contributing factor to the wear may have been the off-label use detailed above.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d10 concomitant devices: 180-01-52, ln: 10143151 - nv crown cup clstr hole 52mm group 2] no cn, ln: 71343204 - femoral head e3 the following sections were corrected: b2 h6 the revision reported was likely 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), including edge loading.Additionally, a contributing factor to the wear may have been the off-label use detailed above.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 relay additional and/or corrected information.The revision reported was likely 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), including edge loading.Additionally, a contributing factor to the wear may have been the off-label use detailed above.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 52MM GROUP 2
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19919705
• Report Number: 1038671-2024-02705
• Device Sequence Number: 15479744
• Product Code: JDI
• UDI-Device Identifier: 10885862037015
• UDI-Public: 10885862037015
• 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: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/25/2019
• Device Catalogue Number: 180-01-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/18/2024; 11/26/2024; 11/26/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 11/08/2024; 12/17/2024; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2014
• 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.; UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female