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

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: 4232090 - 180-01-54 - crown cup,cluster-hole gr.54 -competitor femoral neck prosthesis, sn (b)(6).Pending investigation.

Event 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.

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.

• Brand Name: NV GXL LNR
• Type of Device: 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: michael crader
• MDR Report Key: 18494183
• MDR Text Key: 332677212
• Report Number: 1038671-2024-00079
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862024282
• UDI-Public: 10885862024282
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/02/2024
• Date Device Manufactured: 07/29/2014
• 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 Age: 48 YR
• Patient Sex: Male