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 2020-03-31 for UNKNOWN CONTINUUM SHELL N/A manufactured by Zimmer Biomet, Inc..
[185902623]
(b)(4). Concomitant medical products: catalog#: 00875800928 continuum longevity contained liner with locking ring, lot#: 62134601 medical records were not provided, however review of the additional information by a healthcare professional identified: blood loss should be minimal for this procedure, coming only from the layers incised. Excessive bleeding occurs when reaming the acetabulum, broaching the femoral canal, or an incidental puncture of a major artery. Per surgical technique guidance, these events would not have occurred. As the patient had multiple contributing factors and comorbidities, the death is not related to zimmer biomet devices. As the devices being replaced would not come in contact with any bone or major vessels that would lead to excessive bleeding, decline, and death. Dhr was reviewed and no discrepancies relevant to the reported event were found. The root cause of reported death in the complaint was determined to not be related to zimmer biomet devices. However, a definitive root cause for the liner not seating intraoperatively cannot be determined. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-03616.
Patient Sequence No: 1, Text Type: N, H10
[185902624]
It was reported that during a revision procedure, the surgeon had difficulty reducing the hip, positioning the locking ring greater than 1 hour, and patient sustained excessive bleeding resulting in multiple blood transfusions. Due to the patient? S decline, the surgeon aborted the procedure, secured the locking ring and closed the patient. To replace the ringloc and poly liner, the surgeon makes a deep incision exposing the implants and retracts the large vessels and nerves for adequate exposure. The femoral head is dislocated to expose the head and liner. The liner and locking ring are then disengaged and removed. Postop the patient remained unstable and passed away during the night.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01211 |
| MDR Report Key | 9907871 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2016-09-07 |
| Date Mfgr Received | 2020-03-27 |
| Date Added to Maude | 2020-03-31 |
| 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN CONTINUUM SHELL |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KWA |
| Date Received | 2020-03-31 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| 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. Death; 2. Hospitalization; 3. Other | 2020-03-31 |