MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 50MM GROUP 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV CROWN CUP CLSTR HOLE 50MM GROUP 1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: acetabular liner (cat# 132-32-51), screws (cat# 180-65-30), screws (cat# 180-65-30), femoral stem (cat# 188-00-02), femoral head (cat# 142-32-00).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the exactech hip replacement study, approximately thirteen days post tha, the (b)(6) y/o female patient experienced periprosthetic femoral fracture.A revision of the femoral head and stem was performed nine days later.The event is unlikely related to the device but possibly related to the procedure.The event is noted as ¿resolved¿ on (b)(6) 2021 and the patient was discharged to home care.
Additional Manufacturer Narrative
H3: as reported by the exactech hip replacement study, approximately thirteen days post tha, the 76 y/o female patient experienced periprosthetic femoral fracture.A revision of the femoral head and stem was performed nine days later.The event is unlikely related to the device but possibly related to the procedure.The event is noted as ¿resolved¿ on (b)(6) 2021 and the patient was discharged to home care.Upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, fracture, infection, or loosening of total joint hardware.The most likely cause of the reported event was a malunion of a fracture which was likely caused by over-reaming during implantation.

• Brand Name: NV CROWN CUP CLSTR HOLE 50MM GROUP 1
• Common Device Name: 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
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12149127
• Report Number: 1038671-2021-00336
• Device Sequence Number: 3652457
• Product Code: JDI
• UDI-Device Identifier: 10885862037008
• UDI-Public: 10885862037008
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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: 09/21/2021
• Device Model Number: NV CROWN CUP CLSTR HOLE 50MM GROUP 1
• Device Catalogue Number: 180-01-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 10/31/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Hispanic