MAUDE Adverse Event Report: EXACTECH, INC. MCS GXL LINER 5/15 DEG 5458X32; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number 104-32-45

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 07/11/2023

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a right hip arthroplasty first revision on (b)(6) 2018, and then experienced second revision surgical procedure on (b)(6) 2023 approximately 10 years and 2 months after first revision.Op report dated (b)(6) 2023 - postoperative diagnosis; failed right tha due to asymmetric polywear and osteolysis and pseudotumor (anterior and trochanteric).No images were provided.There is no other information available.

Manufacturer Narrative

D10: concomitants: 4847652 100-32-05 - cocr femoral head 32mm +5mm neck.These devices are used for treatments, not diagnosis.There is no other information available.

• Brand Name: MCS GXL LINER 5/15 DEG 5458X32
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• 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: matt collins
• MDR Report Key: 19123994
• MDR Text Key: 340351040
• Report Number: 1038671-2024-00890
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862013606
• UDI-Public: 10885862013606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/17/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2022
• Device Catalogue Number: 104-32-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 04/17/2024
• Date Device Manufactured: 10/06/2017
• 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-1728-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male