FDA Adverse Event
Injury
Summary report: N
DXTEND STAND PE CUP D42 +6MM
MDR report key: 10995519
·
Received December 12, 2020
Report
- Report Number
- 1818910-2020-26834
- Event Type
- Injury
- Date Received
- December 12, 2020
- Date of Event
- November 12, 2020
- Report Date
- November 13, 2020
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- KWS
- UDI-DI
- 10603295027546
- PMA / PMN Number
- K062250
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
MANUFACTURER REPORT NUMBER 1818910-2020-26834 IS BEING RETRACTED AS IT IS A DUPLICATE OF MRN 1818910-2020-26187. ALL FUTURE REPORTS WILL BE SUBMITTED UNDER MANUFACTURER REPORT NUMBER 1818910-2020-26187 MANUFACTURER REPORT NUMBER 1818910-2020-26834 IS BEING RETRACTED AS IT IS A DUPLICATE OF MRN 1818910-2020-26187. ALL FUTURE REPORTS WILL BE SUBMITTED UNDER MANUFACTURER REPORT NUMBER 1818910-2020-26187.
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
PROCEDURE 3 (B)(6) 2020 (B)(6) HOSPITAL. 42 6 PE CUP 1307-42-206, LOT 5339054 REMOVED AND REPLACED WITH: HUMERAL SPACER 1307-30-009 ,LOT 5336812 AND 42 6 PE CUP 1307-42-206, LOT 5356097.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1461299 | DXTEND STAND PE CUP D42 +6MM | DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP | KWS | DEPUY IRELAND - 9616671 | 130742206 | 10603295027546 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | DXTEND HUMERAL SPACER +9MM| UNKNOWN SHOULDER GLENOSPHERE |