MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH L-SERIES; BIPOLAR HEAD 50MM

Model Number	BP-2850
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.Concomitant device(s): cocr head (cn: 142-28-03, sn/ln: (b)(4)).
Event or Problem Description
Revision of a bipolar because the patient was super active and fractured their pelvis.The patient was stable as they left the operating room and this did not cause a delay.In accordance with hospital policy we are unable to return the explants.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the reported revision of a bipolar head due to the patient was super active and fractured their pelvis.The patient was stable as they left the operating room and this did not cause a delay.In accordance with hospital policy we are unable to return the explants.No other information available at this time.A known surgical risk for total hip revision is potential bone fracture.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.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.The most likely cause for the bone fracture was the patient¿s activity.(d11) concomitant device(s): cocr head (cn: 142-28-03, sn/ln: (b)(6).No information provided in the following section(s): a2, a3, a4, a5, b6, b7, d4 (expiration date), d6, and h4.The following section(s) have additional info; b5, g4, g7, h1, h2, h3, h6, and h7.
Event or Problem Description
Revision of a bipolar head due to the patient was super active and fractured their pelvis.The patient was stable as they left the operating room and this did not cause a delay.In accordance with hospital policy we are unable to return the explants.No other information available at this time.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.The most likely cause for the bone fracture was the patient¿s activity.

• Brand Name: ACUMATCH L-SERIES
• Common Device Name: BIPOLAR HEAD 50MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9195304
• Report Number: 1038671-2019-00516
• Device Sequence Number: 2589603
• Product Code: KWY
• UDI-Device Identifier: 10885862104991
• UDI-Public: 10885862104991
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K905370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: BP-2850
• Device Catalogue Number: BP-2850
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention