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 2020-03-31 for GLOBAL UNITE HEAD 48X18 ECC 1100-48-610 110048610 manufactured by Depuy Ireland - 9616671.
[186797942]
(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
[186797943]
Patient was presented with pain in abduction. Dr. Carried out a scan of the effected shoulder and printed a 3d model of the shoulder, he determined that the humeral head eccentricity was incorrectly placed resulting in the greater tuberosity articulating against the subacromial in abduction. Revision surgery was preformed with humeral head removed and replaced with the same size ecc 48 x 18mm and the eccentricity changed from inferior medial position to superior lateral position. Dr. Carried out range of motion test and determined that greater tuberosity no longer articulated against the subacromial.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09799 |
| MDR Report Key | 9907848 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-17 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2017-01-20 |
| Date Added to Maude | 2020-03-31 |
| 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 DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| 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 48X18 ECC |
| Generic Name | GLOBAL UNITE IMPLANTS : HUMERAL TRIALS |
| Product Code | HSD |
| Date Received | 2020-03-31 |
| Model Number | 1100-48-610 |
| Catalog Number | 110048610 |
| Lot Number | C32541 |
| 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 | 2020-03-31 |