MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 01/12/2024

Event Type  Injury  

Event Description

It was reported that an approximately 71 yo female patient, initial left hip implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2024, approximately 4 years 8 months post the initial implant date.As part of the manufacturer's recall campaign, the patient went to have their left hip prosthesis that was implanted in 2019 checked.The x-ray control showed a clear decentration of the prosthetic head and unusually large osteolysis in the acetabulum as a sign of inlay wear.When changing the inlay the surgeon was able to switch to a vitd-hardened, specially approved inlay (novation xle, neutral liner, group 1, 32mm i.D., ref 140-32-51, sn (b)(6)).As part of the exchange operation, in addition to the inlay exchange, the solid cup integrity was determined as well as curettage and sealing of the cysts in the socket using allogeneic cancellous bone and changing the prosthetic head were performed.No device returns are available for analysis.No further information.

Manufacturer Narrative

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

Manufacturer Narrative

H3: a number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk factors specified in the hhe.However, this cannot be confirmed from the reported information.

• Brand Name: NOVATION
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18705357
• MDR Text Key: 335407796
• Report Number: 1038671-2024-00217
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862207074
• UDI-Public: 10885862207074
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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: 10/10/2022
• Device Model Number: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2017
• 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-1732-2022
• Patient Sequence Number: 1
• Treatment: 5684331 180-01-50 - CROWN CUP,CLUSTER-HOLE GR.50
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female