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

Catalog Number	138-36-52
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation, a patient had left hip replacement surgery on (b)(6) 2009.They underwent left hip revision surgery on (b)(6) 2021, approximately 11 years 1 month post primary procedure.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Concomitants: 1512114 120-65-15 - bone screw 6.5mm dia x 15mm long 1578827 120-65-20 - bone screw 6.5mm dia x 20mm long 1562039 142-36-00 - cocr fem head 36mm +0 offset 12/14 1415514 160-30-11 - pf spline plasma w/ha sz 11 1361874 180-01-52 - nv crown cup clstr hole 52mm group 2 investigation results - based on the available information, the patient involved meets the following risk criteria specified in the hhe: implanted with a lateralized liner and combination of the largest available femora head and/or thinnest available acetabular liner was used.The most likely underlying cause for the revision reported is a combination of risk factors specified in hhe-2020-09-11-02 and being implanted for more than 10 years.

• Brand Name: NV GXL LNR, 10 DEG FACE, 36MM ID, GRP 2 CUP
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: miguel sosa ; 3523782617
• MDR Report Key: 17446733
• Report Number: 1038671-2023-01849
• Device Sequence Number: 17987736
• Product Code: LZO
• 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: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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
• Device Expiration Date: 11/09/2013
• Device Catalogue Number: 138-36-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2009
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female