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

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

Pending investigation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 320278281
• Report Number: 1038671-2023-01849
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862024886
• UDI-Public: 10885862024886
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• 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
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1729-2022
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female