MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; COCR FEM HEAD 28MM +0 OFFSET 12/14

Model Number	142-28-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device: (cn: bp-2854, sn: (b)(4)) bipolar cup, dia.54mm for dia.28mm inner head.
Event or Problem Description
On (b)(6) 2000,14 days post-op, a left hip dislocation of the bipolar cup from the inner head fixed to femoral stem was observed when the post-op x-rays of the patient was taken.Revision surgery of the bipolar cup and the inner head was immediately performed.The dislocated bipolar cup of dia.54mm and the dia.28mm+0mm inner metal head were well fixed to femoral stem and were removed.Replaced to bipolar cup of dia.53mm and dia.28mm + 3.5mm inner head.The locking ring of the retrieved bipolar cup was firmly assembled to the metallic shell and any damages of the polyethylene locking ring was not observed visually at all.There was a 30-45 min delay in surgery, (note: this surgical delay means the surgical time of this revision surgery compared against the surgical time of the primary surgery.The actual primary and revision surgery have been smoothly finished.) this did not cause any adverse event to the patient.Patient continues in follow-up.Devices will return.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the of the revision reported based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the dislocation and subsequent revision cannot be conclusively determined; however, it is most likely is related to the patient¿s underlying condition.(d11) concomitant device: (cn: (b)(4), sn: (b)(6)) bipolar cup, dia.54mm for dia.28mm inner head.No information provided in the following section(s): a2, a4, a5, b6.(d4) (catalog number, serial number, udi number, exp date), d6, g5, h4.

• Brand Name: EXACTECH
• Common Device Name: COCR FEM HEAD 28MM +0 OFFSET 12/14
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10677366
• Report Number: 1038671-2020-00573
• Device Sequence Number: 19606378
• Product Code: JDI
• UDI-Device Identifier: 10885862026774
• UDI-Public: 10885862026774
• Combination Product (Y/N): N
• PMA/510(K) Number: K041906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 02/12/2025
• Device Model Number: 142-28-00
• Device Catalogue Number: 142-28-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention