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 VERSYS FEMORAL STEM NI 00784101400 manufactured by Zimmer Biomet, Inc..
[186665754]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device location is unknown. Once the investigation has been completed, a follow-up mdr will be submitted concomitant medical products: part # 110024463 / liner / lot # 104440, part # 00801802802 / head / lot # 64536302, part # 010000663s / shell / lot # 6581197, part # 00625006515 /bone screw/ lot # 64303525.
Patient Sequence No: 1, Text Type: N, H10
[186665755]
It was reported that patient underwent hip surgery approximately 5 months ago. Patient underwent revision on an unknown date due to periprosthetic fracture of the patient's femur. No products were removed; however, a competitor plate was implanted to correct the 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 | 0001822565-2020-01185 |
| MDR Report Key | 9904383 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-01-14 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSYS FEMORAL STEM |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LPH |
| Date Received | 2020-03-31 |
| Model Number | NI |
| Catalog Number | 00784101400 |
| Lot Number | 64161730 |
| 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 | 2020-03-31 |