MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2019-05-30 for G7 DUAL MOBILITY LINER 38MM C N/A 110024461 manufactured by Zimmer Biomet, Inc..
[146494062]
(b)(4). Concomitant medical products: catalog number: 00625006535, lot number:64190171, brand name: bone screw; catalog number:00625006525, lot number:64124990, brand name: bone screw; catalog number: 00877502802, lot number: 2960402, brand name: biolox delta ceramic head; catalog number: 00771100910, lot number:63994695, brand name: m/l taper stem; catalog number:010000661, lot number:3442540, brand name: g7 acetabular shell; catalog number:xl-200144, lot number: 332220, brand name: act artic hd arcom. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02351, 0001825034-2019-02353. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted in the patient.
Patient Sequence No: 1, Text Type: N, H10
[146494063]
It was reported that the patient underwent hospitalization and a cardiac catheterization due to myocardial infarction approximately 44 days post implantation. Additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-02352 |
| MDR Report Key | 8653835 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-05-30 |
| Date of Report | 2019-11-05 |
| Date of Event | 2019-01-11 |
| Date Mfgr Received | 2019-10-11 |
| Device Manufacturer Date | 2018-11-02 |
| Date Added to Maude | 2019-05-30 |
| 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 DUAL MOBILITY LINER 38MM C |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LPH |
| Date Received | 2019-05-30 |
| Model Number | N/A |
| Catalog Number | 110024461 |
| Lot Number | 599730 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-05-30 |