MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2019-11-18 for G7 NEUTRAL E1 LINER 32MM F N/A 010000850 manufactured by Zimmer Biomet, Inc..
[166779058]
(b)(4). Concomitant medical products: catalog#: 192114 echo por fmrl lat nc 14x150mm lot#: 149220r, catalog#: 163669 32mm mod head cocr std neck lot#: j6336824, catalog#: 010000665 g7 pps ltd acet shell 56f lot#: 6476140. Report source: foreign: (b)(6). The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05197, 0001825034-2019-05199, 0001825034-2019-05201.
Patient Sequence No: 1, Text Type: N, H10
[166779059]
It was reported that the patient underwent a revision procedure approximately two weeks post implantation due to infection. 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 | 0001825034-2019-05202 |
| MDR Report Key | 9334139 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2019-11-18 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-06-07 |
| Date Mfgr Received | 2019-11-07 |
| Device Manufacturer Date | 2018-05-25 |
| Date Added to Maude | 2019-11-18 |
| 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 NEUTRAL E1 LINER 32MM F |
| Generic Name | PROSTHESIS, HIP |
| Product Code | PBI |
| Date Received | 2019-11-18 |
| Model Number | N/A |
| Catalog Number | 010000850 |
| Lot Number | 6283868 |
| 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 | 2019-11-18 |