MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-03 for G7 HI-WALL E1 LINER 32MM F N/A 010000928 manufactured by Zimmer Biomet, Inc..
[189004367]
(b)(4). Report source :(b)(6). Complaint sample was evaluated and the reported event was unable to confirmed. The device was not returned, however a thread like material which appears to be the barb that is used to lock the liner into the ring was returned. Dhr was reviewed and no discrepancies were found. Root cause was unable to be determined. A summary of the investigation has been sent to the complainant. 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
[189004368]
Hold for mrd 04/27/20. It was reported that during a hip procedure, a liner was driven into a shell and was unable to be secured. Once the liner was taken out, a thread-like material came out allowing the liner to seat within the shell. There was no reported harm or injury to the patient. 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 | 0001825034-2020-00779 |
| MDR Report Key | 9779589 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-18 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2017-11-11 |
| Date Added to Maude | 2020-03-03 |
| 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 HI-WALL E1 LINER 32MM F |
| Generic Name | PROSTHESIS, HIP |
| Product Code | PBI |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2019-09-10 |
| Model Number | N/A |
| Catalog Number | 010000928 |
| Lot Number | 6167741 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-03 |