MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-03-02 for DXTEND GLENOSPHERE STD D38MM 130760138 manufactured by Depuy France Sas - 3003895575.
[188143293]
Product complaint #: (b)(4). Investigation summary: the device was examined by the manufacturer and a report was received stating the root cause deterioration during installation. 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 | 1818910-2020-06486 |
| MDR Report Key | 9774896 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-11-25 |
| Date Added to Maude | 2020-03-02 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 INT'L LTD. 8010379 |
| Manufacturer Street | ST ANTHONYS ROAD |
| Manufacturer City | LEEDS LS118 DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8 DT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DXTEND GLENOSPHERE STD D38MM |
| Generic Name | DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE |
| Product Code | HSD |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 130760138 |
| Catalog Number | 130760138 |
| Lot Number | 5353857 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY FRANCE SAS - 3003895575 |
| Manufacturer Address | 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 SAINT PRIEST CEDEX 69801 FR 69801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |