MAUDE Adverse Event Report: EXACTECH, INC. PF STEM TAPERED PLASMA SZ 14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	170-36-00
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the female patient had an initial right tha on (b)(6) 2018.On (b)(6) 2018, about 19 months after the index surgery, the patient presented with severe pain secondary to aseptic loosening of femoral and acetabular implants.The patient was revised on (b)(6)2019.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 130-36-52 - nv gxl liner neutral, 36mm id, group 2 cups, 5329055, 160-00-14 - pf stem tapered plasma sz 14, 4461708, 180-65-30 - alteon 6.5mm screw, 30mm, 5258668, 186-01-54 - integrip cc, cluster 54mm, g2, 4951470, 188-00-08 - wedge plasma s/o sz 8, 5159713, correction/removal number: z-1732-2022.
Additional Manufacturer Narrative
H11.Updated/additional information ¿ d8.G1.G2.G4.H6.The revision reported was likely the result of an insufficient bond between the femoral stem and the bone, which led to aseptic (non-infected) femoral stem loosening.However, this cannot be confirmed as the device was not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of an insufficient bond between the femoral stem and the bone, which led to aseptic (non-infected) femoral stem loosening.However, this cannot be confirmed as the device was not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PF STEM TAPERED PLASMA SZ 14
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15933764
• Report Number: 1038671-2022-01580
• Device Sequence Number: 6563258
• Product Code: JDI
• UDI-Device Identifier: 10885862031693
• UDI-Public: 10885862031693
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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: 06/20/2021
• Device Model Number: 170-36-00
• Device Catalogue Number: 160-00-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 05/15/2024; Not provided
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 06/11/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female