BONE SCR 6.5X20 SELF-TAP N/A 00625006520

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-08-29 for BONE SCR 6.5X20 SELF-TAP N/A 00625006520 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[118649047] (b)(4). Concomitant medical products: item# 00625006530, bone scr 6. 5x30 self-tap, lot# 63592262; item# unknown, unknown screw, lot# unknown; 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 type 1 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: 0001822565-2018-04600, 0002648920-2018-00652.
Patient Sequence No: 1, Text Type: N, H10


[118649050] 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.
Patient Sequence No: 1, Text Type: D, B5


[134876262] Upon receipt of additional information, it has been determined a zimmer biomet device did not cause or contribute to the reported event. The device(s) involved in the event are competitor product. The initial report was forwarded in error and should be voided.
Patient Sequence No: 1, Text Type: N, H10


[134876263] No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2018-04596
MDR Report Key7828471
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2018-08-29
Date of Report2018-11-16
Date of Event2017-04-04
Date Mfgr Received2018-11-07
Device Manufacturer Date2017-02-03
Date Added to Maude2018-08-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameBONE SCR 6.5X20 SELF-TAP
Generic NamePROSTHESIS HIP
Product CodeNLF
Date Received2018-08-29
Model NumberN/A
Catalog Number00625006520
Lot Number63585012
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2018-08-29

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