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 2018-11-19 for BONE SCR 6.5X20 SELF-TAP N/A 00625006520 manufactured by Zimmer Manufacturing B.v..
[127855052]
(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 type1 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. 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. 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
[127855053]
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
| Report Number | 0002648920-2018-00821 |
| MDR Report Key | 8087816 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-11-19 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-04-07 |
| Date Mfgr Received | 2018-12-11 |
| Device Manufacturer Date | 2017-02-03 |
| Date Added to Maude | 2018-11-19 |
| 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 MANUFACTURING B.V. |
| Manufacturer Street | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE SCR 6.5X20 SELF-TAP |
| Generic Name | PROSTHESIS HIP |
| Product Code | NLF |
| Date Received | 2018-11-19 |
| Model Number | N/A |
| Catalog Number | 00625006520 |
| Lot Number | 63585012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER MANUFACTURING B.V. |
| Manufacturer Address | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 MERCEDITA PR 00715 US 00715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-11-19 |