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 2020-03-25 for G7 OSSEOTI 4 HOLE SHELL 60MM G N/A 110010248 manufactured by Zimmer Biomet, Inc..
[185907332]
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: 110003452, g7 str insrtr threaded shaft, lot number unknown, 010002736, g7 ball hex drvr for insr hndl, lot number 061706, 110003451, g7 str modular shell inserter, lot number 253370, multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01274, 0001825034-2020-01277.
Patient Sequence No: 1, Text Type: N, H10
[185907333]
It was reported that the scrub tech unknowingly cross threaded the g7 straight inserter onto the g7 cup during initial tha. Upon impacting the cup into the acetabulum, the inserter became cold welded to the g7 cup. Inserter screwdriver ball tip broke off while trying to disengage inserter from cup. Case was converted to the continuum acetabular system with no impact to the surgeon or the patient. It was reported that no further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01275 |
| MDR Report Key | 9879992 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-25 |
| 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 | G7 OSSEOTI 4 HOLE SHELL 60MM G |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OQI |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-16 |
| Model Number | N/A |
| Catalog Number | 110010248 |
| Lot Number | 6665675 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-25 |