MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-32-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Hip Fracture (2349); Osteolysis (2377); Implant Pain (4561)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation: (d10) concomitant device(s): 2229281 180-01-48 - crown cup,cluster-hole gr.48.
Event or Problem Description
The 84 y/o female patient had persistent pain on her left side in 2013 implanted hip prosthesis after a fall.There was a fracture of the acetabulum.The inlay wear was checked already diagnosed as part of the manufacturer's recall campaign.Suspects also emerged here.Changes noted in the acetabulum as a sign of possible osteolysis.The patient did not want to have the procedure done electively or for further diagnostics.A revision surgery was necessary due to the noted fracture.A revision hip cup with tab and iliac pin (competitor company) was implanted with filling of the osteolysis with allogeneic cancellous bone and changing the prosthetic head.Diagnosis that led to implantation: primary coxarthrosis m16.1 photos of the explants, will be sent upon receipt.The explants are currently in the laboratory doctor's office for microbiological examination using sonication.After the examination (14 days of long-term incubation), these are sent back to us and then - a present one subject to the patient's consent.Surgical reports/x-rays are also available upon request.
Additional Manufacturer Narrative
The revision reported was likely the result of the patient¿s reported fall which led to fracture of the acetabulum.The reported wear and osteolysis may have due to a combination of the risk factors specified in the hhe.However, this cannot be confirmed because the devices were not returned for evaluation and radiographs were not provided.Additionally, the components were implanted for over 10 years which may have contributed to the reported wear.
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 the patient¿s reported fall which led to fracture of the acetabulum.The reported wear and osteolysis may have due to a combination of the risk factors specified such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed because the devices were not returned for evaluation and radiographs were not provided.Additionally, the components were implanted for over 10 years which may have contributed to the reported wear.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18310887
• Report Number: 1038671-2023-02962
• Device Sequence Number: 6783855
• Product Code: JDI
• UDI-Device Identifier: 10885862024275
• UDI-Public: 10885862024275
• 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: 2013
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2025

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
• Device Expiration Date: 02/20/2017
• Device Catalogue Number: 136-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 02/12/2024; 04/17/2025
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/26/2024; 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Female