MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5 LAT 32MM ID, GROUP 4 CUPS; SEE H10

Catalog Number 136-32-54

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented d10.Concomitants: (b)(6), 180-01-60 - crown cup,cluster-hole gr.60.(b)(6), 11-000-440 sl-plus integration plus mia stern lateral with ti/ha (smith & nephew).(b)(6), 71343208 oxinium 32mm o.D.+8 12/14 taper femoral head (smith & nephew).These devices are used for treatment not diagnosis.Pending investigation.

Event Description

It was reported via legal documentation from ous that the patient had a left total hip replacement for coxarthrosis on (b)(6) 2018.The patient had inpatient rehabilitation from (b)(6) 2018 to (b)(6) 2018.The patient was informed on 20 apr 2023 about a recall of his hip device.He had a check-up in (b)(6) 2023, it was determined there that the hip implant had already caused the hip joint to decenter in the socket.Based on these findings, the treating doctors recommended that the patient replace the implant.The revision operation has been scheduled for (b)(6) 2024.Subsequent examinations and the documents from the check-up, confirmed the suspicion that the implant was showing considerable wear and tear and needed to be replaced as quickly as possible, which is why the treating doctors determined that it needed to be revised immediately.The patient claims pain.It is noted that this total implant contains device from two separate companies.There is no other patient demographic or medical history provided.There are no images of the patient/device provided.

Manufacturer Narrative

H10.Additional/updated information- b3, b5, d6b h6.Investigation results- based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified for use of a lateralized liner.The most likely cause for the revision reported due to early prosthesis wear is a combination of the risk factors.Additionally, the exactech acetabular components were used in combination with a competitor¿s femoral components which is considered off-label use.However, prosthesis wear cannot be confirmed as radiographs were not provided and the devices remained implanted at the time of evaluation.There is no other information available.

Event Description

The x-ray control showed a clear decentering of the prosthetic head and unusually large osteolysis in the acetabulum as a sign of inlay wear.Revision on (b)(6) 2024.

• Brand Name: NV GXL LNR, +5 LAT 32MM ID, GROUP 4 CUPS
• Type of Device: SEE H10
• 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 ; 3523771140
• MDR Report Key: 17816558
• MDR Text Key: 324237426
• Report Number: 1038671-2023-02372
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862024305
• UDI-Public: 10885862024305
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2019
• Device Catalogue Number: 136-32-54
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male