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 2018-09-21 for UNKNOWN SHOULDER GLENOSPHERE UNK SHOULDER GLENOSPHERE manufactured by Depuy Orthopaedic Inc, 1818910.
[120984562]
(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
[120984563]
The patient was revised to address pain and loosening of the glenosphere to metaglene at the bone to implant interface due to fall. Surgeon opened the shoulder and saw metallosis explanted the +9mm spacer/38 +3 poly, 38 ecc head and discovered the central screw was broken and the metaglene was loose. Explanted 4 screws, all parts/broken parts retrieved and converted to a delta cta head. Doi: unknown. Dor: (b)(6) 2018. Right shoulder.
Patient Sequence No: 1, Text Type: D, B5
[126533046]
Product complaint #: (b)(4). Investigation summary: no device associated with this report was received for examination. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. 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
| Report Number | 1818910-2018-70025 |
| MDR Report Key | 7897509 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-21 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-08-28 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2018-09-21 |
| 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 | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDIC INC, 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN SHOULDER GLENOSPHERE |
| Generic Name | SHOULDER HUMERAL HEADS |
| Product Code | MJT |
| Date Received | 2018-09-21 |
| Catalog Number | UNK SHOULDER GLENOSPHERE |
| 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 ORTHOPAEDIC INC, 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-21 |