MAUDE Adverse Event Report: EXACTECH, INC. UNKNOWN HIP COMPONENTS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	COCR FEM HEAD 28MM +0 OFFSET 12/14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 44 days post initial left side tha, the female patient was brought back for a dislocated left bipolar hip.The bipolar shell and 28 head were removed.The stem checked and found to be well fixed.A competitor's dual mobility cup and an exactech 28 +3.5 head was then implanted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photo received.Sales rep was unable to obtain x-rays.The device is not available for evaluation as it was discarded by hospital.No other patient information/medical history reported.
Additional Manufacturer Narrative
Concomitant medical products: bipolar head 48mm (cat# bp-2848 / serial#(b)(4)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, approximately 44 days post initial left side tha, the female patient was brought back for a dislocated left bipolar hip.The bipolar shell and 28 head were removed.The stem checked and found to be well fixed.A competitor's dual mobility cup and an exactech 28 +3.5 head was then implanted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photo received.Sales rep was unable to obtain x-rays.The device is not available for evaluation as it was discarded by hospital.No other patient information/medical history reported.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, infection, dislocation, or loosening of total joint hardware.The most likely cause of the reported event is the patient conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4(remove all from the initial report-suspect device unknown) e4 (remove erroneous entry from initial report), g4 (remove 501k from the initial report-unknown), h4 (remove erroneous date from initial report-unknown, h6: component code, type of investigation and investigation conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: UNKNOWN HIP COMPONENTS
• 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: 16308514
• Report Number: 1038671-2023-00107
• Device Sequence Number: 17843194
• Product Code: JDI
• UDI-Device Identifier: 10885862026774
• UDI-Public: 10885862026774
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

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: COCR FEM HEAD 28MM +0 OFFSET 12/14
• Device Catalogue Number: 142-28-00
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 01/31/2026
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 05/21/2023; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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