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 2019-03-13 for LARGE METAPHYSIS RASP STRAIGHT N/A 00789201380 manufactured by Zimmer Biomet, Inc..
[138700178]
(b)(4). Concomitant medical devices: versys fiber metal midcoat stem # item 00784101330 lot 64161727. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-01116. 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.
Patient Sequence No: 1, Text Type: N, H10
[138700179]
It was reported that during a hip surgery, the broach fitted in the femur easily, but during implanting stem it was tight and the femur got cracked. Cables were applied to get the stem in. The rasp used and the actual implant had different profiles and the surgeon is suspecting that the rasp id of wrong size. A delay of 30-45 min occurred during the procedure for application of cable to reduce fracture. 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 | 0001822565-2019-01117 |
| MDR Report Key | 8417678 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-03-13 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-08-20 |
| Device Manufacturer Date | 2001-02-01 |
| Date Added to Maude | 2019-03-13 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LARGE METAPHYSIS RASP STRAIGHT |
| Generic Name | PROSTHESIS HIP |
| Product Code | HTR |
| Date Received | 2019-03-13 |
| Model Number | N/A |
| Catalog Number | 00789201380 |
| 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. Required No Informationntervention | 2019-03-13 |