MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS; 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 Code	Failure of Implant (1924)
Date of Event	03/16/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation from ous that a patient had a total hip arthroplasty for an unknown side on (b)(6) 2015.It is stated that during an examination on (b)(6) 2023, "it was found that a slight decentration of the femoral head in the socket was a sign of (premature; author's note) inlay wear." there is no other information provided.
Additional Manufacturer Narrative
H10.D10.Concomitant: 3709308 - 180-01-52 - crown cup, cluster-hole gr.52 pending investigation.These devices are used for treatment not diagnosis.There is no other information provided.
Additional Manufacturer Narrative
H10.Additional information- h6 health effect - impact code.H3.Investigation findings- based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the health evaluations: implanted with a lateralized liner.The most likely cause for the monitoring reported due to early prosthesis wear is a combination of the risk factors.However, this cannot be confirmed from the reported information.There is no additional information available.

• Brand Name: NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
• 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 ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 18855004
• Report Number: 1038671-2024-00424
• Device Sequence Number: 3306843
• 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: 2015
• 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
• Report Date (Section B): 05/28/2024

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: 07/21/2019
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female