MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/08/2023

Event Type  Injury  

Event Description

As reported by the germany competent authorities, the patient presented for several follow-up checks with persistent symptoms on the opposite side.The x-ray control revealed a clear decentering of the prosthetic head.The ct scan also showed osteolysis in the acetabulum as a sign of premature inlay wear.This was verified when the inlay was changed on (b)(6) 2023 to a vitd-hardened, specially approved inlay (novation xle, neutral liner group 3, 36 mm i.D).As part of the replacement operation, in addition to the inlay replacement, the firm socket integrity was determined as well as the curettage and sealing of the cysts in the socket using allogeneic cancellous bone and the replacement of the prosthetic head.The explants are currently in the laboratory doctor's office for microbiological examination using sonication.After the examination (14 days of long-term incubation).

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

The prosthesis wear reported may have been due to a combination of the risk factors specified in the hhe, 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, surgical approach, or any combination of these possibilities.However, this cannot be confirmed since the devices were not returned for evaluation and radiographs were not provided.

• Brand Name: NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson
• MDR Report Key: 18330501
• MDR Text Key: 330523950
• Report Number: 1038671-2023-02980
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862022172
• UDI-Public: 10885862022172
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS
• Device Catalogue Number: 130-32-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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-1729-2022
• Patient Sequence Number: 1
• Treatment: CROWN CUP INLAY NEUTRAL GR.3,32MM; CROWN CUP,CLUSTER-HOLE GR.56; CROWN CUP,CLUSTER-HOLE GR.58
• Patient Outcome(s): Required Intervention
• Patient Sex: Male