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 2020-01-13 for G7 NEUTRAL E1 LINER 36MM E N/A 010000857 manufactured by Zimmer Biomet, Inc..
[174697824]
(b)(4). Concomitant medical products: 650-1067 cer option type 1 tpr sleve +3 2959173, 650-1057 cer bioloxd option hd 36mm 2958828, item #: unknown stem lot #: unknown, item #: unknown cup lot #: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[174697825]
It was reported patient underwent irrigation and debridement one month post implantation due to infection. Liner and head components were removed and replaced. Further information is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-00214 |
| MDR Report Key | 9580824 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2019-12-31 |
| Device Manufacturer Date | 2019-04-18 |
| Date Added to Maude | 2020-01-13 |
| 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 36MM E |
| Generic Name | PROSTHESIS, HIP |
| Product Code | PBI |
| Date Received | 2020-01-13 |
| Model Number | N/A |
| Catalog Number | 010000857 |
| Lot Number | 6515598 |
| 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 | 2020-01-13 |