MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-03-13 for G7 PPS LTD ACET SHELL 52E N/A 010000663 manufactured by Zimmer Biomet, Inc..
[183373768]
(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 which would have minimal, if any impact on the patient, as the body will replenish a minimal blood loss without any intervention. 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.
Patient Sequence No: 1, Text Type: N, H10
[183373769]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01069 |
| MDR Report Key | 9829262 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-08-10 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | G7 PPS LTD ACET SHELL 52E |
| Generic Name | PROSTHESIS, HIP |
| Product Code | PBI |
| Date Received | 2020-03-13 |
| Model Number | N/A |
| Catalog Number | 010000663 |
| Lot Number | 6578868 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-13 |