MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, 10 DEG FACE, 36MM ID, GRP 2 CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	138-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal notification, the female patient had an initial left tha on 10/14/2010.Following a period of post-implantation recovery and for years after the replacement surgeries, the patient's exactech hip devices performed as expected.The patient was revised on (b)(6) 2018 due to polyethylene liner wear resulting in periprosthetic osteolysis and reactive synovitis.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: novation acetabular cup, catalog no.180-01-52, lot no.1746419; novation femoral stem, catalog no.160-33-11, lot no.0962122; and femoral head, catalog no.142-36-00, lot no.1885730.
Additional Manufacturer Narrative
Correction made to g3.
Additional Manufacturer Narrative
H3.Investigation results- the patient/gxl acetabular liner involved was reportedly revised due to prosthesis wear, osteolysis and synovitis approximately 7 years and 3 months after the index surgery.However, the revised components were not returned to exactech for evaluation and no images or radiographs were provided.Based on the available information, the patient involved meets risk criteria for early prosthesis wear: combination of largest available femoral head and/or thinnest available acetabular liner was used, and patients implanted with a lateralized liner.The most likely underlying cause for the revision due to early prosthesis wear is a combination of risk factors.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.These devices are used for treatment not diagnosis.There is no other information available.H11.Correction ¿ section f should be blank.
Event or Problem Description
Revision operative report of 20-mar-2018- for left hip periprosthetic osteolysis, polyethylene wear of acetabular liner, reactive synovitis.Femoral head and liner exchange.Patient was revised to exactech devices.There were no noted surgical complications.The patient was taken to pacu in stable condition.There is no other information provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3, d8, f6, g2, h6: clinical codes, component code, type of investigation and investigation findings.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, 10 DEG FACE, 36MM ID, GRP 2 CUP
• 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: 16582459
• Report Number: 1038671-2023-00463
• Device Sequence Number: 20003878
• Product Code: JDI
• UDI-Device Identifier: 10885862024886
• UDI-Public: 10885862024886
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/21/2026

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: 02/14/2014
• Device Model Number: 138-36-52
• Device Catalogue Number: 138-36-52
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 02/27/2023; 01/22/2024; 01/15/2026
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 03/21/2023; 03/06/2024; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female