FDA Adverse Event
Injury
Summary report: N
SMARTSET HV BONE CEMENT 40G
MDR report key: 9510995
·
Received December 23, 2019
Report
- Report Number
- 1818910-2019-124470
- Event Type
- Injury
- Date Received
- December 23, 2019
- Date of Event
- July 5, 2017
- Report Date
- July 5, 2017
- Manufacturer
- DEPUY CMW - 9610921
- Product Code
- LOD
- UDI-DI
- 10603295168331
- PMA / PMN Number
- K023012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. 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. DEVICE HISTORY LOT: 8151376.
Additional Manufacturer Narrative · 1
(B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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
PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE, DEPUY CEMENT WAS USED. DOI: (B)(6) 2015; DOR: (B)(6) 2017; RIGHT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1305623 | SMARTSET HV BONE CEMENT 40G | BONE CEMENT : BONE CEMENT | LOD | DEPUY CMW - 9610921 | 3092-040 | 8151376 | 10603295168331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |