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

Catalog Number 130-32-52

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient, initial hip implanted on an unknown date, underwent a revision procedure on (b)(6), 2023.The inlay was replaced with a 140-36-52 cc inlay vitamin e, neutral, ø 36, gr.2.No further information known at this time.

Manufacturer Narrative

H3: the most likely cause for the revision reported due to early prosthesis wear could include a number of variables including use error, implant positioning, implant size selection, and patient factors.Additionally, increased shelf oxidation resulting from the use of nylon vacuum bags without evoh could also have contributed to the wear.However, this cannot be confirmed as the devices were not available for evaluation and no clinical data was provided.H7: the product associated with the reported event is within the scope of recall z-1729-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.

Manufacturer Narrative

Duplicate event already reported under mdr# (b)(4).

• 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; gainseville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18401425
• MDR Text Key: 331428967
• Report Number: 1038671-2023-03060
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2024

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: 04/15/2024
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 06/12/2024; 07/10/2024
• Supplement Dates FDA Received: 06/13/2024; 07/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2019
• 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