MAUDE Adverse Event Report: EXACTECH, INC. PF STEM TAPERED PLASMA EXT OFFSET SZ 13; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	PF STEM TAPERED PLASMA EXT OFFSET SZ 13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: 180-01-48, nv crown cup clstr hole 48mm group 1.130-28-51, nv gxl linr, ntrl, 28mm id, group 1 cups.142-28-00, cocr fem head 28mm +0 offset 12/14 (screw x2).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 clinical study, approximately five-year post tha, the patient experienced mechanical fall, the mid shaft femur fx left orif.Patient had labs repairing surgical procedure two days later.The event is possibly related to the device and not related to the procedure.
Additional Manufacturer Narrative
As reported by the exactech hip replacement clinical study, approximately five-year post tha, the patient experienced mechanical fall, the mid shaft femur fx left orif.Patient had labs repairing surgical procedure two days later.The event is possibly related to the device and not related to the procedure.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: PF STEM TAPERED PLASMA EXT OFFSET SZ 13
• 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 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12433045
• Report Number: 1038671-2021-00463
• Device Sequence Number: 12102584
• Product Code: JDI
• UDI-Device Identifier: 10885862031808
• UDI-Public: 10885862031808
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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 Model Number: PF STEM TAPERED PLASMA EXT OFFSET SZ 13
• Device Catalogue Number: 160-01-13
• 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: 08/17/2021
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 86 KG