FDA Adverse Event
Injury
Summary report: N
AEQUALIS REVERSED INSERT
MDR report key: 8377496
·
Received February 28, 2019
Report
- Report Number
- 3000931034-2019-00033
- Event Type
- Injury
- Date Received
- February 28, 2019
- Date of Event
- January 23, 2019
- Report Date
- January 31, 2019
- Manufacturer
- TORNIER S.A.S.
- Product Code
- KWS
- UDI-DI
- 03700386916540
- PMA / PMN Number
- K050316
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.
Additional Manufacturer Narrative · 1
THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.
Description of Event or Problem · 1
PATIENT WHO HAD ASCEND RSA IMPLANT INITIAL SURGERY ON (B)(6) 2014. AFTER THIS INITIAL SURGERY, DISLOCATION OCCURRED ON (B)(6) 2019. SINCE THE SURGEON DETERMINED THAT DISLOCATION OCCURRED DUE TO SOME INFLUENCE OF THE THICKNESS OF THE INSERT, THE STANDARD HUMERAL INSERTS 36 MM + 6 MM (DWB993) WAS REMOVED. AND THE HUMERAL SPACER 36 MM + 9 MM (DWB 931) AND CONSTRAINED HUMERAL INSERTS 36 MM + 6 MM (DWD 980) WAS NEWLY INSTALLED AND OPERATION WAS COMPLETED WITHOUT PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172859 | AEQUALIS REVERSED INSERT | SHOULDER JOINT POLYMER PROSTHESIS | KWS | TORNIER S.A.S. | STANDARD D36MM TH. +6MM | 3718AO | 03700386916540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |