PINN CAN BONE SCREW 6.5MMX20MM
Received Dec 16, 2019
Report 1818910-2019-123158 · MDR key 9474305
Device
Generic name
Bone Screws And Pins : Screws
Manufacturer
Depuy Orthopaedics Inc UsModel number
1217-20-500Catalog number
121720500
Lot number
A4JCL4000
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
- Weakness
- Pain
- Weakness
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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative
(B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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
PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN AND WEAKNESS AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, THERE IS NO REVISION REPORTED. DOI: (B)(6) 2015 (HEAD, LINER); DOI: (B)(6) 2007 (CUP, SCREW, STEM,SLEEVE); DOR: NONE REPORTED (LEFT HIP) . PLEASE SEE (B)(4) FOR THE LEFT HIP FIRST REVISION.