MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-24 for G7 OSSEOTI 4 HOLE SHELL 54MM F NI 110010245 manufactured by Zimmer Biomet, Inc..
[186107573]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was discarded by hospital. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to 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. Udi #: (01) 0 0880304 54420 8 (17) 290304 (10) 6497857. Concomitant medical products: item # unknown/unknown head/ lot # unknown, item # unknown/ unknown liner/ /lot # unknown, item # unknown/ unknown stem/ /lot # unknown.
Patient Sequence No: 1, Text Type: N, H10
[186107574]
It was reported during a hip surgery, that one of the caps in the 4-hole shell could not be removed. 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 | 0001825034-2020-01233 |
| MDR Report Key | 9873310 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-09-09 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-02-20 |
| Date Added to Maude | 2020-03-24 |
| 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 | G7 OSSEOTI 4 HOLE SHELL 54MM F |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LZO |
| Date Received | 2020-03-24 |
| Model Number | NI |
| Catalog Number | 110010245 |
| Lot Number | 6497857 |
| 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 | 2020-03-24 |