MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; PROSTHESIS HIP

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Blood Loss (2597)

Event Date 04/07/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item# 00625006530, bone scr 6.5x30 self-tap, lot# 63592262; item# 00625006520, bone scr 6.5x20 self-tap, lot# 63585012; item# 650-1055, cer bioloxd option hd 28mm, lot# 236390; item# 110024463, g7 dual mobility liner 42mm e, lot# 592890; item# 51-107140, tprlc 133 mp type1 pps ho 14.0, lot# 3925972; item# ep-200148, act artic e1 hip brg 28x42mm, lot# 213650; item# 650-1065, cer option type 1 tpr sleve -3, lot# unknown; item# 010000663, g7 pps ltd acet shell 52e, lot# 3921114.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 04596; 0002648920 - 2018 - 00652.

Event Description

It was reported during an initial total hip arthroplasty, the patient experienced increased blood loss of 1-2 liters.While reaming the acetabulum, a central defect was created with the reamer.During closure, it was noticed there was too much blood welling up.Sutures were removed and the hip was dislocated.Bleeding was coming from the cancellous bone at the margins of the cup and from the inferior portion of the obturator.It was attempted to pack these with thrombin and gelfoam, but it was unsuccessful.The patient¿s pressures dropped and became unstable, requiring multiple units of packed red blood cells, ffp, and epinephrine.Bone wax was used to seal the cancellous bone around the cup and femur.The bleeding had improved.Another dose of arista powder, thrombin gelfoam, and a gram of vancomycin powder were placed.The capsule was then closed.The patient was transferred to interventional radiology where an angiogram found no vessel injury.It was noted that one of the acetabular screws that had been cut to size during the procedure, still appeared to be too long; however, there was no vessel damage or bleeding as a result.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes which indicated during procedure brisk bleeding from the cancellous bone at the margin of the cup and from the inferior portion of the obturator was noted.Due to patient experiencing a significant drop in blood pressure resulting in patient instability, multiple units of packed red blood cells, ffp, and epinephrine was required.Bone wax was used to seal the cancellous bone around the cup and also around the femur.The wound was irrigated and bleeding had reduced.Another dose of arista powder, thrombin gelfoam, a gram of vancomycin powder was placed into the wound and the capsule was closed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN SCREW
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7828478
• MDR Text Key: 118621599
• Report Number: 0001822565-2018-04600
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention