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 2019-04-30 for G7 OSSEOTI ACETABULAR SHELL MULTI HOLE N/A 110010266 manufactured by Zimmer Biomet, Inc..
[143610326]
(b)(4). Concomitant medical products: part: 110024464, g7 dual mobility liner 44mm f, lot: 166300. Part: ep-200150, act artic e1 hip brg 28x44mm, lot: 820730. Part: 00801802802, femoral head sterile product 12/14 taper, lot: 64156841. Part: 010000996, g7 screw, lot: 6456735. Part: 010000996, g7 screw, lot: 6352938. Part: 010000997, g7 screw, lot: 6329780. Part: 010000999, g7 screw, lot: 6478743. Part: 31-323220, ringloc + acetabular drill bit, lot: 182840. Part: 31-323240, ringloc + acetabular drill bit, lot: 951390. Part: 013593, smith and nephew suture retriever, lot: 2018785. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital. 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
[143610327]
It was reported that a patient underwent an initial right hip procedure and subsequently, was revised one week later due to cup loosening. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-01829 |
| MDR Report Key | 8566586 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-30 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-04-06 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2018-12-12 |
| Date Added to Maude | 2019-04-30 |
| 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 OSSEOTI ACETABULAR SHELL MULTI HOLE |
| Generic Name | PROSTHESIS, HIP |
| Product Code | PBI |
| Date Received | 2019-04-30 |
| Model Number | N/A |
| Catalog Number | 110010266 |
| Lot Number | 6453028 |
| 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; 2. Required No Informationntervention | 2019-04-30 |