MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NOVATION CROWN CUP CLUSTER HOLE 50MM GROUP 1

Model Number	180-01-50
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.Concomitant medical products: cocr femoral head 32mm +3.5 offset (cn: 142-32-03, sn: (b)(4); nv gxl liner 10o 32mm (cn: 138-32-51, sn: (b)(4); screw 30mm 6.5 (cn: 120-65-30, sn: (b)(4); c-series 2nd offset 12/14 size 1 (cn: 116-30-01, sn: (b)(4).
Event or Problem Description
Original right total hip arthroplasty was performed on this female patient on (b)(6) 2009.The surgeon brought the patient in because their acetabular cup and liner were spun out and loose when he looked at their x-ray.The surgeon opened the joint in standard fashion.The surgeon decided to pull everything out and implant stryker femoral components and acetabular components.The patient left the operating room in stable condition and is expected to have a good outcome.There was no delay to the surgery.The rep was present at the time of the surgery.The hospital did not release implants to be returned to exactech.
Additional Manufacturer Narrative
The evaluation noted that the reason for the revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening of the acetabular cup.However, this cannot be confirmed since the devices were not returned for evaluation.(d11) concomitant device(s): cocr femoral head 32mm +3.5 offset (cn:(b)(4), sn: (b)(6).Nv gxl liner 10o 32mm (cn:(b)(4), sn: (b)(6).Screw 30mm 6.5 (cn:(b)(4), sn: (b)(6).C-series 2nd offset 12/14 size 1 (cn:(b)(4), sn: (b)(6).

• Brand Name: NOVATION
• Common Device Name: NOVATION CROWN CUP CLUSTER HOLE 50MM GROUP 1
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9139393
• Report Number: 1038671-2019-00475
• Device Sequence Number: 2693037
• Product Code: JDI
• UDI-Device Identifier: 10885862037008
• UDI-Public: 10885862037008
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2014
• Device Model Number: 180-01-50
• Device Catalogue Number: 180-01-50
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR