FDA Adverse Event
Malfunction
Summary report: N
SPACER IMPACTOR TIP
MDR report key: 6732339
·
Received July 21, 2017
Report
- Report Number
- 1818910-2017-21518
- Event Type
- Malfunction
- Date Received
- July 21, 2017
- Date of Event
- April 24, 2017
- Report Date
- June 23, 2017
- Manufacturer
- DEPUY ORTHOPAEDICS, INC. 1818910
- Product Code
- HWA
- UDI-DI
- 10603295116011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative · 1
PREVIOUS MEDWATCHES IS LINKED TO COM-(B)(4) PRODUCT COMPLAINT # ==> PC-(B)(4). INVESTIGATION SUMMARY ==> EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE COMPLAINT. 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
IT WAS REPORTED THAT THE POLY TIPS OF THE IMPACTOR WAS WORN OUT. (B)(6) 2017 - EVALUATION OF THE RETURNED TIPS FOUND TWO LOTS WITH PIECES OF MATERIAL MISSING. LOTS 5236860 & 5091011 K. POTTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513148 | SPACER IMPACTOR TIP | SHOULDER INSTRUMENT/TRIAL | HWA | DEPUY ORTHOPAEDICS, INC. 1818910 | 5091011 | 10603295116011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |