FDA.reportPublic FDA data

MAUDE MDR 9829262

MDR report key
9829262
Report number
0001825034-2020-01069
Event key
0
Event type
3
Date of event
2020-02-05
Date received
2020-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CHRISTINA ARNT
Address
56 E. BELL DR. WARSAW IN 46582 US
Phone
574-574-5745
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1G7 PPS LTD ACET SHELL 52EPROSTHESIS, HIPZIMMER BIOMET, INC.PBIN/A0100006636578868R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1301. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). CONCOMITANT MEDICAL PRODUCT(S): 010000857-G7 NEUTRAL E1 LINER 36MM E-6592218; 192008-ECHO POR FMRL NC 8X120MM-083280; 12-115120-CER BIOLOXD MOD HD 36MM-2986013. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 01072, 0001825034 - 2020 - 01073. THE HUMAN BODY CONSISTS OF 4-5 LITERS OF BLOOD. ANY TYPE OF BLOOD LOSS HAS THE POTENTIAL TO CAUSE A COMPLICATION HOWEVER; IT IS USUALLY THE LARGE, RAPID BLOOD LOSS DURING SURGERY OR A TRAUMA THAT WILL MOST LIKELY CAUSE COMPLICATIONS. THE AMOUNT OF BLOOD LOSS THAT MAY LEAD TO INTRA AND/OR POSTOPERATIVE COMPLICATIONS DEPENDS ON THE INDIVIDUAL PERSON AND COMORBIDITIES, SUCH AS BODY MASS INDEX, GENDER, LOW PRE-OPERATIVE HEMOGLOBIN LEVELS, MEDICATIONS AND/OR THE PRESENCE OF CERTAIN HEALTH CONDITIONS SUCH AS ANEMIA, HEMOPHILIA, ETC., AS WELL AS DURATION OF SURGERY. AS BLOOD LOSS EFFECTS ARE BASED ON INDIVIDUAL FACTORS, TREATMENT DEPENDS ON THE AMOUNT OF BLOOD LOSS, HOW QUICKLY IT WAS LOST AND THE INDIVIDUALS HEALTH STATE. FOR LARGER BLOOD LOSS, A BLOOD TRANSFUSION OR ALTERNATIVE MAY BE NEEDED. HEMORRHAGE IS CLASSIFIED INTO 4 CATEGORIES 1-4. CLASS I HEMORRHAGE - MINIMAL BLOOD LOSS 750ML IS CONSIDERED TO HAVE LARGER IMPACT AND THEREFORE THE POTENTIAL FOR MEDICAL INTERVENTION, I.E. BLOOD TRANSFUSION, OR OTHER ALTERNATIVE TREATMENT. AS THE COMPLAINT INDICATES INTRAOP BLOOD LOSS GREATER THAN 750 ML, THE PATIENT HAD DIAGNOSIS OF ACUTE POSTOP BLOOD LOSS ANEMIA AND WAS SYMPTOMATIC, MEDICAL INTERVENTION OF BLOOD TRANSFUSION (1 UNIT PRBCS) WAS ADMINISTERED, AND THE PATIENT'S HOSPITALIZATION WAS EXTENDED; THEREFORE, COMPLAINT CATEGORIES OF MEDICAL: BLOOD LOSS AND MEDICAL: PROCEDURE RELATED WOULD BE APPROPRIATE. REMAINS IMPLANTED.

D

Patient 1

IT WAS REPORTED THAT A STUDY PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY THAT RESULTED WITH 800ML OF BLOOD LOSS. SUBSEQUENTLY, ON POSTOP DAY 1, THE PATIENT EXPERIENCED TACHYCARDIA AND FATIGUE THAT RESULTED IN A BLOOD TRANSFUSION AND EXTENDED HOSPITALIZATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.