FDA Adverse Event
Malfunction
Summary report: N
ATTUNE RP TIBIAL IMPACTOR
MDR report key: 7943648
·
Received October 8, 2018
Report
- Report Number
- 1818910-2018-71643
- Event Type
- Malfunction
- Date Received
- October 8, 2018
- Date of Event
- September 26, 2018
- Report Date
- September 26, 2018
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- HWA
- UDI-DI
- 10603295130208
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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 2 RP IMPACTORS WERE BROKEN UPON IMPACTION OF THE TIBIAL BASE-PLATE WHILE CEMENTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 785840 | ATTUNE RP TIBIAL IMPACTOR | ATTUNE INSTRUMENTS : IMPACTORS | HWA | DEPUY IRELAND - 9616671 | AU3664789 | 10603295130208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |