SMARTSET GHV GENTAMICIN 40G
Report
- Report Number
- 1818910-2018-62877
- Event Type
- Injury
- Date Received
- June 21, 2018
- Date of Event
- January 10, 2017
- Report Date
- May 30, 2018
- Manufacturer
- DEPUY CMW - 9610921
- Product Code
- LOD
- UDI-DI
- 10603295174288
- PMA / PMN Number
- K033563
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: H6 PATIENT CODE: NO CODE AVAILABLE (3191) WAS USED TO CAPTURE SURGICAL INTERVENTION. PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT :DEVICE HISTORY REVIEWED: 4 UNRELATED NON CONFORMANCES ON THIS BATCH. MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 1 ADDITIONAL REPORT RELATED TO IMPLANT LOOSENING, AND 3 FURTHER UNRELATED REPORTS. TOTAL FOR LOT NUMBER: 4 (B)(4). COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE BY PRODUCT CODE: 60. BY PRODUCT FAMILY: 182 (63X SMARTSET GHV, 119X SMARTSET GMV).
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT DEVICE HISTORY REVIEWED: 4 UNRELATED NON CONFORMANCES ON THIS BATCH. MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 1 ADDITIONAL REPORT RELATED TO IMPLANT LOOSENING, AND 3 FURTHER UNRELATED REPORTS. TOTAL FOR LOT NUMBER: 4 ((B)(4)) COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: (B)(4). BY PRODUCT FAMILY: 182 (63X SMARTSET GHV, 119X SMARTSET GMV). DEVICE HISTORY BATCH NULL DEVICE HISTORY REVIEW NULL IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: DEVICE HISTORY REVIEWED: 4 UNRELATED NON CONFORMANCE'S ON THIS BATCH. MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 1 ADDITIONAL REPORT RELATED TO IMPLANT LOOSENING, AND 3 FURTHER UNRELATED REPORTS. TOTAL FOR LOT NUMBER: 4 (B)(4). COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 60 BY PRODUCT FAMILY: 182 (63X SMARTSET GHV, 119X SMARTSET GMV). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
UDI: (B)(4). (B)(4) WAS ADDED TO CAPTURE MEDICAL DEVICE REMOVAL.
RECEIVED MEDICAL RECORDS ON 5/30/2018. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PATIENT HAD BILATERAL ATTUNE TOTAL KNEES. PATIENT'S LEFT ATTUNE TOTAL KNEE REPLACEMENT WAS REVISED TO ADDRESS PAIN AND PROBABLE ASEPTIC TIBIAL TRAY IMPLANT LOOSENING. REVISING SURGEON INDICATED PRESENCE OF LARGE JOINT EFFUSION AND SCAR TISSUE. NOTED THAT THE TIBIAL TRAY WAS GROSSLY LOOSE, WITH THE TIBIAL INSERT AND TRAY BEING REMOVED BY HAND AS A SINGLE UNIT. TIBIAL CEMENT MANTLE REQUIRED REMOVAL BY INSTRUMENTS. THE FEMUR COMPONENT WAS WELL-ALIGNED AND FIXED, AND NOT REVISED, NOR WAS THE PATELLA COMPONENT. REVISING SURGEON DISCOVERED ON REVISION POST-OPERATIVE X-RAYS THAT AN INTRAOPERATIVE POSTERIOR PROXIMAL TIBIA PERFORATING FRACTURE HAD OCCURRED, CAUSED BY THE REVISION TIBIAL STEM. THIS REQUIRED ANOTHER REVISION SURGERY, WHICH IS ADDRESSED IN (B)(4). PATIENT HAD AN ATTUNE RIGHT KNEE REVISION ADDRESSED IN (B)(4). DOI: (B)(6) 2016; DOR: (B)(6) 2017; (LEFT KNEE).
MEDICAL RECORDS ALLEGES EDEMA AND ADHESION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469729 | SMARTSET GHV GENTAMICIN 40G | BONE CEMENT : BONE CEMENT | LOD | DEPUY CMW - 9610921 | 5450-35-500 | 8159147 | 10603295174288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention | ATTUNE MEDIAL ANAT PAT 35MM| ATTUNE PS FEM LT SZ 6 NAR CEM |