PINN CAN BONE SCREW 6.5MMX25MM
Received Sep 3, 2020 · Event occurred Aug 19, 2020
Report 1818910-2020-19363 · MDR key 10488011
Device
Generic name
Bone Screws And Pins : Screws
Manufacturer
Depuy Orthopaedics Inc UsModel number
1217-25-500Catalog number
121725500
Lot number
D19043303
Product problems
- Loss of Osseointegration
- Loss of Osseointegration
Patient
80 YR
- Pain
- Inadequate Osseointegration
- No Code Available
- Pain
- Inadequate Osseointegration
- No Code Available
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
Additional Manufacturer Narrative
(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
IT WAS REPORTED THAT THE PATIENT COMPLAIN OF HIP PAIN, ACETABULAR CUP WAS LOOSE, REVISED CUP. DOI: (B)(6) 2019, DOR: (B)(6) 2020, UNKNOWN AFFECTED SIDE.