MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	136-32-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	07/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10.Concomitants: 4232090 - 180-01-54 - crown cup,cluster-hole gr.54 -competitor femoral neck prosthesis, sn (b)(6).Pending investigation.
Event or Problem Description
It was reported via ous legal documentation that a patient had a right total hip replacement on (b)(6) 2016.Based on the subsequent findings and examinations carried out by the hospital, it was determined that the prosthetic head needed to be revised.The patient has advanced coxarthrosis.The patient is scheduled to have revision surgery on (b)(6) 2024.No revision at this time.There is no other information provided.
Additional Manufacturer Narrative
H10.H3.Investigation results - the patient/gxl acetabular liner involved in was reported as a pending revision due to early prosthesis wear approximately 6.5 years after the index surgery.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis: implanted with a lateralized liner.The most likely cause for the pending revision reported due to early prosthesis wear is a combination of the risk factors.However, this cannot be confirmed from the reported information.
Additional Manufacturer Narrative
H6: corrected.

• Brand Name: NV GXL LNR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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
• MDR Report Key: 18494183
• Report Number: 1038671-2024-00079
• Device Sequence Number: 20580762
• Product Code: LZO
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2024

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: Lay User/Patient
• Device Expiration Date: 09/24/2019
• Device Catalogue Number: 136-32-52
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 04/16/2024; 10/09/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 05/07/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• 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
• 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 Age: 48 YR
• Patient Sex: Male