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

Model Number	NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products crown cup,cluster-hole gr.58 (cat# 180-01-58 / serial# (b)(6)) crown cup,cluster-hole gr.50 (cat# 180-01-50 / serial# (b)(6) ) crown cup inlay neutral gr.3,32mm (cat# 130-32-53 / serial# (b)(6) ) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by german competent authorities, part of the manufacturer's recall campaign, the patient went to have the device implanted in 2018 checked hip prosthesis.The x-ray control showed a clear decentering of the prosthetic base and unusually large osteolysis in the acetabulum as a sign of premature inlay wear.The patient was revised to an inlay change on (b)(6), 2023 to a vitd-hardened, specially approved inlay (novation xle extended coverage liner, group 1, ref (b)(4) sn (b)(6)).As part of the replacement operation; in addition to the inlay replacement, the solid cup integrity was determined as well as curettage and sealing the cysts in the socket using allogeneic spongiosa and changing the prosthetic head.As per information received the item data of the implantation and replacement, as well as photos of the explants, will be sent upon receipt.Confirmation of receipt with bfarm case number submitted later.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 competent authorities and then a present one subject to the patient's consent - contact the manufacturer upon request for further material-related information investigation provided.Surgical reports/x-rays are also available upon request.
Additional Manufacturer Narrative
Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: implanted with a lateralized liner, combination of largest available femoral head and/or thinnest available acetabular liner was used, and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to prosthesis wear and osteolysis is 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6.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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson
• MDR Report Key: 18051926
• Report Number: 1038671-2023-02651
• Device Sequence Number: 15473079
• 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: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2024

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: 03/28/2020
• Device Model Number: NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS
• Device Catalogue Number: 136-32-51
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 01/18/2024; 11/19/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 05/07/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female