SIDUS STEM-FREE SHLDRHUM ANCHOR L
Report
- Report Number
- 9613350-2016-00109
- Event Type
- Injury
- Date Received
- January 29, 2016
- Date of Event
- February 17, 2014
- Report Date
- June 30, 2020
- Product Code
- KWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
AS PER FDA¿S DIRECTIVE, MEDWATCH REPORT HAS BEEN RESUBMITTED FOR REMOVING THREE ZEROS IN THE PREFIX OF MFR NUMBER(0009613350-2016-00109-1). ALL THE INFORMATION CAPTURED HEREIN INCLUDING G4 (DATE RECEIVED BY MANUFACTURER) EXCEPT B4. ADDITIONAL: H2, H5. UPDATE: G4, G7, H6, H10. NO TREND IDENTIFIED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. THE MANUFACTURER DID NOT RECEIVE THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION AS THE PATIENT HAS NOT BEEN REVISED. REVIEW OF INCOMING INFORMATION. IT IS REPORTED THAT THE PATIENT HAD AN INCREASE IN GLENOHUMERAL SUBLUXATION FROM 1MM AT 6 WEEKS FOLLOW-UP TO 2MM AT 6 MONTH FOLLOW-UP VISIT. X-RAYS 6 WEEKS POST-OPERATIVE: A-P AND AXILLARY VIEW OF THE RIGHT SHOULDER WITH SIDUS STEM FREE SHOULDER AND A.S. GLENOID CEMENTED TSA. THE COMPONENTS SEEMS TO BE IMPLANTED IN THE CORRECT POSITION. NO SIGNS OF LOOSENING VISIBLE, NEITHER ON THE HUMERAL SIDE NOR ON THE GLENOID. BONE QUALITY SEEMS TO BE GOOD. X-RAYS 6 MONTHS POST-OPERATIVE: A-P AND AXILLARY VIEW OF THE RIGHT SHOULDER WITH SIDUS STEM FREE SHOULDER AND A.S. GLENOID CEMENTED TSA. COMPARING THE A-P EXTERNAL VIEW WITH THE 6-WEEKS-POST-OPERATIVE X-RAY IT SEEMS THAT THE DISTANCE FROM HUMERAL COMPONENT RESPECT TO GLENOID HAS REDUCED. THIS COULD BE DUE TO A DIFFERENT ARM POSITION DURING X-RAY CAPTURING OR DUE TO FRONTAL PARTIAL LUXATION. NO SIGNS OF LOOSENING VISIBLE, NEITHER ON THE HUMERAL SIDE NOR ON THE GLENOID. BONE QUALITY SEEMS TO BE GOOD. X-RAYS 12 MONTHS POST-OPERATIVE: A-P AND AXILLARY VIEW OF THE RIGHT SHOULDER WITH SIDUS STEM FREE SHOULDER AND A.S. GLENOID CEMENTED TSA. THE QUALITY OF THESE IMAGES IS VERY POOR. IT IS VERY DIFFICULT TO RECOGNIZE DIFFERENCES RESPECT TO 6-MONTHS POST-OPERATIVE X-RAYS. NO SIGNS OF LOOSENING VISIBLE, NEITHER ON THE HUMERAL SIDE NOR ON THE GLENOID. BONE QUALITY SEEMS TO BE GOOD. SURGICAL REPORT OF IMPLANTATION DATED (B)(6) 2013: 65-YEAR-OLD MALE PATIENT UNDERWENT TO RIGHT TSA DUE TO GLENOHUMERAL ARTHRITIS. HUMERAL HEAD OSTEOTOMY HAS BEEN PERFORMED IN NATURAL RETROVERSION AND INCLINATION WITH 135 DEGREES ANGLE. A GLENOID 10 DEGREES OF RETROVERSION CORRECTION HAS BEEN PERFORMED. NO OTHER CONSPICUOUS INFORMATION. NO OTHER DOCUMENTS WERE PROVIDED. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION AS THE PATIENT HAS NOT BEEN REVISED. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO PERFORM. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA. LINE 28 : FAILURE OF HUMERAL HEAD-GLENOID INTERFACE -> DUE TO SUBLUXATION DUE TO INCOMPATIBLE GLENO-HUMERAL CURVATURE. LINE 43 : POOR RECONSTRUCTION WHICH MAY DISASSEMBLE (INSUFFICIENT PRIMARY STABILITY) IN-VIVO -> DUE TO TOO LOW IMPACTION FORCES DURING INSERTION OF THE ANCHOR. LINE 47 : PERFORMANCE OF THE ASSEMBLED SYSTEM DOES NOT FUNCTION AS INTENDED IN-VIVO -> DUE TO IMPLANT COMPONENTS ARE DAMAGED DUE TO INSTRUMENTS --> DURING INSERTION/ASSEMBLY/EXTRACTION. LINE 53 : POOR POST-OPERATIVE OUTCOME. -> DUE TO IMPLANTS USED FOR DEFINED CONTRA-INDICATION. LINE 55 : POOR POST-OPERATIVE OUTCOME. -> DUE TO MALALIGNMENT OF THE ANCHOR INTO HUMERUS DUE TO INCORRECT RESECTION ANGLE AND IRREGULAR SURFACE. LINE 56 : POOR POST-OPERATIVE OUTCOME. -> DUE TO MALALIGNMENT OF THE ANCHOR INTO HUMERUS DUE TO INCORRECT PREPARATION OF THE HUMERAL BONE. COMPARISON TO INVESTIGATION RESULTS WHETHER IT IS POSSIBLE AND JUSTIFICATION: LINE 28 : NOT POSSIBLE -> COMPATIBILITY ACCORDING SURGICAL TECHNIQUE. LINE 43 : POSSIBLE -> PRODUCT STILL IMPLANTED, CANNOT BE EXCLUDED. MOREOVER SUBLUXATION OBSERVED IN THE X-RAYS COULD BE A CONSEQUENCE OF THAT. LINE 47 : POSSIBLE -> PRODUCT STILL IMPLANTED, CANNOT BE EXCLUDED. MOREOVER SUBLUXATION OBSERVED IN THE X-RAYS COULD BE A CONSEQUENCE OF THAT. LINE 53 : NOT POSSIBLE -> NOTHING SUGGEST CONTRA INDICATIONS. LINE 55 : NOT POSSIBLE -> ACCORDING X-RAYS, THE ANCHOR SEEMS TO BE WELL POSITIONED. LINE 56 : NOT POSSIBLE -> ACCORDING X-RAYS, THE ANCHOR SEEMS TO BE WELL POSITIONED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT A PATIENT WAS IMPLANTED A SIDUS STEM-FREE SHLDRHUM ANCHOR L ON (B)(6) 2013 ON THE RIGHT SIDE. IT WAS REPORTED THAT X-RAYS INDICATE AN INCREASE IN GLENOHUMERAL SUBLUXATION FROM 1MM AT 6 WEEKS FOLLOW-UP TO 2MM AT 6 MONTH FOLLOW-UP VISIT ON (B)(6) 2014.
THE MANUFACTURER DID NOT RECEIVE DEVICES AS THE PATIENT HAS NOT BEEN REVISED. X-RAYS AND OTHER SOURCE DOCUMENTS WERE RECEIVED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4). STILL IMPLANTED.
IT WAS REPORTED THAT A PATIENT WAS IMPLANTED A SIDUS STEM-FREE SHLDRHUM ANCHOR L ON (B)(6) 2013 ON THE RIGHT SIDE. IT WAS REPORTED THAT X-RAYS INDICATE AN INCREASE IN GLENOHUMERAL SUBLUXATION FROM 1MM AT 6 WEEKS FOLLOW-UP TO 2MM AT 6 MONTH FOLLOW-UP VISIT ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56306 | SIDUS STEM-FREE SHLDRHUM ANCHOR L | UNKNOWN | KWS | NA | 2706760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |