FDA Adverse Event
Malfunction
Summary report: N
PFC* PATELLAR CEMENTING CLAMP
MDR report key: 7058173
·
Received November 26, 2017
Report
- Report Number
- 1818910-2017-50215
- Event Type
- Malfunction
- Date Received
- November 26, 2017
- Date of Event
- October 30, 2017
- Report Date
- October 30, 2017
- Manufacturer
- DEPUY ORTHOPAEDICS, INC. 1818910
- Product Code
- HXD
- UDI-DI
- 10603295216605
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT # : (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT # ==> PC-(B)(4). INVESTIGATION SUMMARY ==> EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED THE RUBBER RING COMPONENT IS DAMAGED AS REPORTED. 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
(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
IT WAS REPORTED THAT THE PATELLA CLAMP WOULD NOT RELEASE. NO PIECES CAME OFF OF THE CLAMP. THE INNER MECHANISM WAS DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837321 | PFC* PATELLAR CEMENTING CLAMP | KNEE TRIAL/INSTRUMENT | HXD | DEPUY ORTHOPAEDICS, INC. 1818910 | UNK | 10603295216605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |