MAUDE Adverse Event Report: EXACTECH, INC. 12/14 ZIRCONIA HEAD 28MM +3.5MM NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	148-28-03
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 1899409 148-28-03 - 12/14 zirconia head 28mm +3.5mm neck 2033349 164-01-11 - element-stem, collarless w/ha, std offset, sz 11 2037328 180-01-48 - nv crown cup clstr hole 48mm group 1.
Event or Problem Description
Approximately 12 years 7 months after right primary total hip replacement, the patient returned complaining of pain and dissatisfaction with their left primary hip.The poly and a recalled implant were worn upon examination and imaging.The patient underwent revision where the stem, head, and liner were removed.A new liner was implanted into the cup and a competitors stem and the head was implanted into the femoral side.This event is not related to the breakage of a device.The event did not lead to a surgical prolongation/delay.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Correction: d1 d2a, d2b, d4, h4.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-02443, 038671-2024-02129.This follow-up report is being submitted to relay additional and/or corrected information.The most likely underlying cause for the revision reported is a combination of risk factors such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) "and being implanted for more than 10 years.However, this cannot be confirmed from the reported information and the devices were 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: 12/14 ZIRCONIA HEAD 28MM +3.5MM NECK
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19611474
• Report Number: 1038671-2024-02130
• Device Sequence Number: 17916542
• Product Code: LPH
• UDI-Device Identifier: 10885862027801
• UDI-Public: 10885862027801
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2025
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2015
• Device Catalogue Number: 148-28-03
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 06/14/2024; 02/11/2025
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/18/2024; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2010
• 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; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male