MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 130-32-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.H7: z-2117-2021.

Event Description

As part of the manufacturer's recall campaign, the patient went to have the device implanted in 2016 checked hip prosthesis.The x-ray control showed a clear decentering of the prosthetic head, osteolysis in the acetabulum as a sign of inlay wear.This was possible when the inlay was changed on (b)(6) 2023 on a vitd-hardened, specially approved inlay (novation xle neutral liner, group 2, 32mm i.D., ref 140-32-52, (b)(6)).As part of the replacement operation, the inlay was replaced.Determination of the solid cup integrity as well as the curettage and sealing of the cysts in the cup bed using allogenic spongiosa and changing the prosthetic head.

Manufacturer Narrative

H3: the prosthesis wear reported may have been due to a combination of the risk factors specified, such as use error, implant positioning, implant size selection, patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential), the use of nylon vacuum bags without evoh, and/or surgical approach.However, this cannot be confirmed since the devices were not returned for evaluation and radiographs were not provided.

• Brand Name: NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
• Type of Device: 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18334285
• MDR Text Key: 330593943
• Report Number: 1038671-2023-02990
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862022165
• UDI-Public: 10885862022165
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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: 11/10/2020
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female