MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X30 SELF-TAP; PROSTHESIS HIP

Model Number N

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

(b)(4).Concomitant medical products: item# 00625006520 bone scr 6.5x20 self-tap lot# 63585012.Item# unknown, unknown screw lot# unknown.Item# 650-1055 cer bioloxd option hd 28 mm lot# 236390.Item# 110024463 g7 dual mobility liner 42 mm e lot# 592890.Item# 51-107140 tprlc 133 mp type1 pps ho 14.0 lot# 3925972.Item# ep-200148 act artic e1 hip brg 28 x 42 mm 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: 0001822565-2018-04600, 0001822565-2018-04596.

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.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated.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) was reviewed and no discrepancies relevant to the reported event were found.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.

Manufacturer Narrative

It was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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 information available.

• Brand Name: BONE SCR 6.5X30 SELF-TAP
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 7828460
• MDR Text Key: 118728943
• Report Number: 0002648920-2018-00652
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: PK934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2018

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
• Device Catalogue Number: 00625006530
• Device Lot Number: 63592262
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention