MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-09 for GLOBAL UNITE HEAD 44X18 ECC 1100-44-610 110044610 manufactured by Depuy Ireland - 9616671.
[182726972]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[182726973]
The patient was revised due to pain, stiffness and loosening of the glenoid component at cement to implant interface. Depuy cement was used. It was also reported that the head was exchanged and a new 44 glenoid was cemented in place. Doi: (b)(6) 2019; dor: (b)(6) 2020; left shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07189 |
| MDR Report Key | 9806165 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-03-13 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLOBAL UNITE HEAD 44X18 ECC |
| Generic Name | GLOBAL UNITE IMPLANTS : HUMERAL TRIALS |
| Product Code | HSD |
| Date Received | 2020-03-09 |
| Model Number | 1100-44-610 |
| Catalog Number | 110044610 |
| Lot Number | J2780D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-09 |