MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW 6.5X35MM; PROSTHESIS, HIP

Catalog Number	103534
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/29/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported a patient underwent a hip revision approximately two weeks post the initial procedure because a proper fit was not able to be obtain between the liner and the shell during the initial procedure.There was this delay between the two procedures due to needing to obtain compatible blood products for the patient.The surgery itself was also prolonged due to numerous complications including excessive bleeding, incorrect component positioning, femur fracture, and additional difficulty with implant placement.Ultimately, satisfactory implantation was achieved and the procedure concluded.However, the patient is reported to have expired within 4 hours after the conclusion of the procedure.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01388, 0001825034-2023-01389, 0001825034-2023-01390, 0001825034-2023-01760, 0001825034-2023-01759.D10: cat #: 11-363663 / 36mm cocr mod hd +3mm / lot #: j7044498, cat #: 010000937 / g7 hi-wall e1 liner 36mm g / lot #: 6751535, cat #: 11-300915 / arcos 15x190mm spl tpr dist / lot #: 846880, cat #: 11-301352 / arcos con sz b hi 80mm / lot #: 880450, cat #: 110017107 / g7 finned 4 hole shell 60g / lot #: 7173931.G2: mexico.Further review of this specific case identified that the patient had multiple comorbidities and compromise prior to the procedure for completion of an unsuccessful hip arthroplasty and was closed without implants.Due to the patient¿s comorbid state of kidney insufficiency, hemodynamic instability, and recent implantation of a pacemaker, the surgery was delayed while attempting to obtain an additional six units of compatible blood product.Due to the patient¿s blood type, only three units were obtained and the surgeon proceeded with an extensive five hour surgery.As reported, the patient experienced excessive bleeding throughout the approach and acetabular wall preparation, which was further complicated by malfunctioning of the suction unit and the availability of compatible blood units.It was reported that blood loss was then controlled manually throughout the procedure, however it is unclear from the information available if a backup suction unit was available, if electrocautery was utilized, and how much blood was lost or provided to the patient.Of note, as the surgeon initially requested an additional six units of blood, while only three were obtained, blood loss control would be critical.Due to the loss of suction, the dexterity and visualization diminished throughout the procedure.The entrance into the hip through the existing incision lasted approximately 1 hour and an additional 1 hour for the acetabular wall preparation.As this patient was recently opened for an unsuccessful arthroplasty, the approach should not have been complicated by encountering scar tissue and as the patient was prepped to receive implants during prior attempt, the procedure time would presumably be shortened.After closure, the patient was taken to the recovery area and expired 4 hours later.Overall, a total of three units of blood were available prior to surgery while the total administered and pharmaceutical intervention taken during and after surgery is unknown.Prolonged operative duration increases the risk for surgical related complications and adversely affects patient outcomes.From the information provided, it appears the outcome of death is a culmination of the patient¿s comorbidities, peri-operative hemodynamic optimization and instability, excessive bleeding, impacted dexterity, diminished visualization, and intra-operative events resulting in prolonged operative duration.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TI LOW PROFILE SCREW 6.5X35MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17408610
• Report Number: 0001825034-2023-01761
• Device Sequence Number: 20308370
• Product Code: KWA
• UDI-Device Identifier: 00880304005785
• UDI-Public: (01)00880304005785(17)281019(10)990230
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K082446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

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 Catalogue Number: 103534
• Device Lot Number: 990230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Sex: Male