MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-32-52
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.
Event or Problem Description
As reported, the patient had an initial tha on an unknown date.The patient was revised on (b)(6) 2024; reason unknown.No further information provided at this time.
Additional Manufacturer Narrative
Section h10: (h3) a number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.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.The revision reported was likely the result of a combination of both patient-related conditions and the risk factors specified in an hhe including but not limited to use error, implant positioning, implant size selection, and patient factors, which led to polyethylene wear.However, this cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.Section h11: *the following sections have corrected information: (d1) brand name: nv gxl lnr, +5lat, 32mm g2-52/54mm cups.(d10) concomitant device(s): (b)(6), 180-01-54 - crown cup,cluster-hole gr.54.(h6) medical device problem code: 2988.
Event or Problem Description
It was reported that this 62 y/o female patient's left hip was revised approximately 5 years post op.As part of the follow-up care after hip prosthesis implantation on the left, inlay wear was observed in an asymmetrical manner.Head position diagnosed by the resident colleagues.The patient presented herself with the x-rays control.The x-ray control showed a clear decentering of the prosthetic head and unusually large osteolysis in the acetabulum and greater trochanter as a sign of premature inlay wear.This was possible when the inlay was changed on (b)(6), 2024 to a specially approved vitd-hardened one.Inlay (novation xle +5mm, lateralized liner, group 2, 36 mm i.D., ref 146-36-52, sn (b)(6)) can be verified.As part of the replacement operation, in addition to the inlay replacement, the solid cup integrity was determined as well as the curettage and filling of the cysts in the socket and in the greater trochanter using allogeneic cancellous bone and changing the prosthetic head.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code, component code, investigation findings, and investigation conclusions.

• Brand Name: NV GXL LNR, +5LAT, 32MM G2-52/54MM 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 66th ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18677958
• Report Number: 1038671-2024-00186
• Device Sequence Number: 6155736
• Product Code: JDI
• UDI-Device Identifier: 10885862024282
• UDI-Public: 10885862024282
• 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: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2023
• Device Catalogue Number: 136-32-52
• 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: 01/24/2024
• Supplement Date Received by Manufacturer: 04/12/2024; 11/19/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 04/23/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown