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 2019-05-02 for GLOBAL UNITE STD STEM SZ 6 110006100 manufactured by Depuy Ireland 9616671.
[143826410]
(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
[143826411]
Removal of all shoulder arthroplasty components; continued history of pain and stiff shoulder since surgery. All components removed, discarded, and temporary prosthesis (global ap with cta head) implanted with antibiotic cement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-92253 |
| MDR Report Key | 8573332 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-06-14 |
| Device Manufacturer Date | 2014-10-13 |
| Date Added to Maude | 2019-05-02 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY IRELAND 9616671 |
| Manufacturer Street | LOUGHBEG RINGASKIDDY CO. |
| Manufacturer City | CORK IN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLOBAL UNITE STD STEM SZ 6 |
| Generic Name | GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS |
| Product Code | MBF |
| Date Received | 2019-05-02 |
| Catalog Number | 110006100 |
| Lot Number | 7992649 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-05-02 |