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 2020-03-13 for DXTEND HUMERAL SPACER +9MM 130730009 manufactured by Depuy France Sas - 3003895575.
[186330138]
(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
[186330139]
The patient was revised to address a draining wound. Surgeon elected to perform an i&d with glenosphere, poly, and spacer exchange. No loosening and no surgical delay reported. Doi: (b)(6) 2020. Dor: (b)(6) 2020, right shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07830 |
| MDR Report Key | 9831006 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2018-12-10 |
| Date Added to Maude | 2020-03-13 |
| 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. B.P. 256 |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | LEEDS MFG & MATERIAL WAREHOUSE |
| Manufacturer Street | ST ANTHONYS ROAD |
| Manufacturer City | LEEDS LS118DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8DT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DXTEND HUMERAL SPACER +9MM |
| Generic Name | DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER |
| Product Code | HSD |
| Date Received | 2020-03-13 |
| Model Number | 130730009 |
| Catalog Number | 130730009 |
| Lot Number | 5331372 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2020-03-13 |