SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 50-21
Report
- Report Number
- 0009613350-2018-00601
- Event Type
- Injury
- Date Received
- June 11, 2018
- Date of Event
- April 26, 2018
- Report Date
- November 12, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- HSD
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL: IF FOLLOW-UP, WHAT TYPE. CORRECTION: DATE OF REPORT, DATE REC¿D BY MFR, PMA/510K. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A CONCESSION WAS FOUND THAT HAS NO EFFECT ON THE EFFECTIVENESS OF THE PRODUCT. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: RADIOLUCENCY. EVENT SUMMARY: IT HAS BEEN REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN AS GLENOID SHOULDER ON (B)(6) 2014 AND DURING POST OPERATIVE FOLLOW UP ON (B)(6) 2018, GRADE 1 RADIOLUCENCY WAS NOTED. REVIEW OF RECEIVED DATA SURGICAL REPORT: DATE OF SURGERY: ON (B)(6) 2014, SURGEON: (B)(6) MD. PROCEDURE: LEFT TOTAL SHOULDER ARTHROPLASTY WITH SIDUS IMPLANT, BICEPS TENODESIS AND RELATED PROCEDURES. PREOPERATIVE DIAGNOSIS: LEFT SHOULDER OSTEOARTHRITIS WITH BICEPS TENOSYNOVITIS. PROCEDURE PERFORMED: LEFT TOTAL SHOULDER ARTHROPLASTY WITH SIDUS IMPLANT, BICEPS TENODESIS. COMPLICATIONS: NONE. SPECIMENS: NONE. IMPLANTS: SIDUS STEM-FREE HUMERAL ANCHOR: REF: (B)(4), LOT: 2711344, SIDUS STEM-FREE HUMERAL HEAD: REF:(B)(4), LOT: 2706769, ANATOMICAL SHOULDER GLENOID CEMENTED: REF: (B)(4), LOT: 2747148, PALACOS GENTAMICIN CEMENT. INDICATIONS: THE PATIENT HAS HAD AN ONGOING HISTORY OF SHOULDER PAIN WHICH HAS BEEN GRADUALLY INCREASING IN SEVERITY. THEY HAVE SEVERE NIGHT TIME PAIN AND PAIN WITH REALLY ANY ACTIVITY WHATSOEVER USING THE SHOULDER. THEY HAVE FAILED MULTIPLE CONSERVATIVE MEASURES. THEY HAD PREOPERATIVE IMAGING WHICH DOCUMENTED THE ABOVE-MENTIONED PATHOLOGY. DESCRIPTION OF PROCEDURE: PALACOS WITH GENTAMICIN CEMENT WAS THEN PRESSURIZED USING A TOOMEY SYRINGE INTO THE VAULT THROUGH THE HOLES OF THE GLENOID. THIS WAS PRESSURIZED FOR SEVERAL ROUNDS OF CEMENT PLACEMENT. SOME ADDITIONAL CEMENT WAS THEN PLACED ON THE BACK OF THE COMPONENT AND THE LARGE ANATOMIC SHOULDER GLENOID COMPONENT WAS THEN PUT INTO POSITION, SEATED FLUSH WITH THE FACE OF THE GLENOID, AND HELD IN POSITION UNTIL ALL CEMENT HAD HARDENED. ANY EXCESS CEMENT AROUND THE PERIPHERY WAS REMOVED. THIS WAS WELL FIXED IN BOTH ROTATION AND TRANSLATION TESTING WITH GOOD POSITION AND GOOD SEATING ON THE GLENOID FACE. AT THIS POINT THE SIOUS STEM-FREE SHOULDER HUMERAL LARGE ANCHOR WAS PUT IN POSITION AND IMPACTED. IT WAS WELL FIXED IN AN APPROPRIATE HEIGHT AND DEPTH AND IN GOOD POSITION, AND WAS VERY SECURE. IT SHOULD BE NOTED THAT PRIOR TO MAKING THE REAMING STEP COMPLETE, THE BONE QUALITY WAS TESTED BY PUSHING ON THE PROXIMAL BONE WHICH HAD ADEQUATE STRUCTURE FOR THIS TYPE OF DEVICE. THE FINAL HEAD WAS THEN PLACED IN POSITION. THIS WAS A 50 X 21 SIDUS STEM-FREE SHOULDER HUMERAL HEAD. THIS WAS WELL SEATED AND WELL FIXED WITH GOOD ANATOMIC RESTORATION OF THE PROXIMAL HUMERUS. SHOULDER WAS THEN REDUCED AND ONCE AGAIN CHECKED THROUGHOUT ALL RANGE OF MOTION WITH NO SIGNS OF IMPINGEMENT AND APPROPRIATE TENSION ON ALL SOFT TISSUES, 50% POSTERIOR TRANSLATION WITH GOOD BOUNCE BACK TO CENTER OF GLENOID, 25% INFERIOR TRANSLATION WITH GOOD BOUNCE BACK TO CENTER OF GLENOID, AND GOOD RANGE OF MOTION. ONCE AGAIN THE ARM WAS TAKEN THROUGH FULL RANGE OF MOTION AND HAD GOOD OVERALL STABILITY AND APPROPRIATE TENSION ON ALL SOFT TISSUES, GOOD FIXATION, WITH APPROPRIATE TENSION ON THE SUBSCAPULARIS, WITH GOOD HEMOSTASIS NOTED. PROGRESS NOTES AT 6 WEEKS ON (B)(6) 2014: PATIENT ATTENDING PT 3 TIMES PER WEEK. X-RAY: LEFT SHOULDER AP, AXILLARY AND SCAPULAR Y VIEWS SHOW THE SIDUS TSA IMPLANT TO BE IN GOOD, STABLE POSITION, WELL FIXED IN BOTH GLENOID AND HUMERUS. NO SIGNS OF SHIFTING OR LOOSENING. NO SIGNS OF PERIPROSTHETIC FRACTURE, SUBLUXATION, OR DISLOCATION. JOINT SPACE WELL REDUCED. PLAN: CONTINUE ICE, NSAIDS, PAIN MEDICATION AS NEEDED. WE HAVE DISCUSSED CONTINUING TO WEAN OFF PAIN MEDICATION ON THEIR OWN. WE WILL CONTINUE TO DECREASE DOSAGE OF MEDICATION AS WELL OVER THE NEXT FEW WEEKS. PROGRESS NOTES AT 5 MONTHS ON (B)(6) 2015: PATIENT ATTENDING PT 2 TIMES PER WEEK, AND IS DOING A HOME EXERCISE PROGRAM. HAS RETURNED TO ACTIVITIES AS ABLE. X-RAY: LEFT SHOULDER AP, AXILLARY AND SCAPULAR Y VIEWS TAKEN IN THE OFFICE TODAY, AND REVIEWED AND INTERPRETED BY ME, SHOW THE SIDUS TSA IMPLANT TO BE IN GOOD, STABLE POSITION, WELL FIXED IN BOTH GLENOID AND HUMERUS. NO SIGNS OF SHIFTING OR LOOSENING. NO SIGNS OF PERIPROSTHETIC FRACTURE, SUBLUXATION, OR DISLOCATION. JOINT SPACE WELL REDUCED. PLAN: IMPROVING. WORKING HARD ON HIS OWN WITH HEP AND AT GYM. OK FOR SWIMMING. OFF PAIN MEDS. PROGRESS NOTES AT 12 MONTHS ON (B)(6) 2015: HE IS DOING WELL AND PROGRESSING IN PHYSICAL THERAPY. PATIENT ATTENDING PT 1 TIMES PER WEEK, AND IS DOING A HOME EXERCISE PROGRAM. HE FEELS LIKE HIS MOTION HAS IMPROVED AND HE CONTINUES TO WORK ON HIS STRENGTH. HE HAS RETURNED TO ACTIVITIES AS ABLE. X-RAY: LEFT SHOULDER AP, AXILLARY AND SCAPULAR Y VIEWS TAKEN IN THE OFFICE TODAY, AND REVIEWED AND INTERPRETED BY ME, SHOW THE SIDUS TSA IMPLANT TO BE IN GOOD, STABLE POSITION, WELL FIXED IN BOTH GLENOID AND HUMERUS. NO SIGNS OF SHIFTING OR LOOSENING. NO SIGNS OF PERIPROSTHETIC FRACTURE, SUBLUXATION, OR DISLOCATION. JOINT SPACE WELL REDUCED. THERE IS SOME CALCIFICATION AT THE INFERIOR POUCH BUT NO CHANGE FROM LAST XRAYS. PLAN: HE HAS MADE GREAT IMPROVEMENTS IN HIS MOTION AND STRENGTH. HE WILL CONTINUE HIS HEP FOLLOW UP IN 12 MONTHS FOR ROUTINE STUDY FOLLOW UP. PROGRESS NOTES AT 22 MONTHS ON (B)(6) 2016: HE IS DOING VERY WELL AND ONLY REPORTS OCCASIONAL STIFFNESS. PATIENT IS NOT ATTENDING PT, AND IS DOING A HOME EXERCISE PROGRAM. HIS AROM IS VERY GOOD. HE HAS RETURNED TO ACTIVITIES AS ABLE. X-RAY: LEFT SHOULDER AP, AXILLARY AND SCAPULAR Y VIEWS TAKEN IN THE OFFICE TODAY, AND REVIEWED AND INTERPRETED BY ME, SHOW THE SIDUS TSA IMPLANT TO BE IN GOOD, STABLE POSITION, WELL FIXED IN BOTH GLENOID AND HUMERUS. NO SIGNS OF SHIFTING OR LOOSENING. NO SIGNS OF PERIPROSTHETIC FRACTURE, SUBLUXATION, OR DISLOCATION. JOINT SPACE WELL REDUCED. THERE IS SOME CALCIFICATION AT THE INFERIOR POUCH BUT NO CHANGE FROM LAST XRAYS. PROGRESS NOTES AT 42 MONTHS ON (B)(6) 2018: PATIENT ATTENDING PT O TIMES PER WEEK, AND IS DOING A PHYSICIAN DIRECTED EXERCISE PROGRAM, FOCUSING ON RANGE OF MOTION AND STRETCHING, ALONG WITH ROTATOR CUFF AND DELTOID SPECIFIC STRENGTHENING. HAS RETURNED TO ACTIVITIES AS ABLE. X-RAY: LEFT SHOULDER AP, AXILLARY AND SCAPULAR YVIEWS TAKEN IN THE OFFICE TODAY, AND REVIEWED AND INTERPRETED BY ME. SHOW THE TSA IMPLANT TO BE IN GOOD, STABLE POSITION, WELL FIXED IN BOTH GLENOID AND HUMERUS. NO SIGNS OF SHIFTING OR LOOSENING. NO SIGNS OF PERIPROSTHETIC FRACTURE, SUBLUXATION, OR DISLOCATION. JOINT SPACE WELL REDUCED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS AS ALL COMPONENTS REMAINED IMPLANTED. REVIEW OF PRODUCT DOCUMENTATION THE COMPATIBILITY CHECK WAS PERFORMED USING SURGICAL TECHNIQUE AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: MECHANICAL LOOSENING DUE TO CEMENTED FIXATION OF THE POLY GLENOID DESTABILISES, LEADING TO LOOSENING OF THE PROSTHESIS FROM THE GLENOID BONE POSSIBLE, AS THIS CANNOT BE EXCLUDED BASED ON THE GIVEN MEDICAL DOCUMENTATION AND THE PROVIDED X-RAYS. INADEQUATE RANGE OF MOTION, OR GLENOID LOOSENING DUE TO PROVIDED SCOPE OF IMPLANTS DOES NOT MEET ANATOMICAL REQUIREMENTS NOT POSSIBLE, AS THE X-RAY ANALYSIS AND THE MEDICAL DOCUMENTATION CONFIRMED THE IMPLANT CHOICE WITH RESPECT TO ANATOMICAL REQUIREMENTS. IMPAIRED DEVICE PERFORMANCE DUE TO HCP OR PATIENT DEVIATE FROM NORMAL POST-OPERATIVE REGIMEN POSSIBLE, AS NO INFORMATION ABOUT THE POST-OPERATIVE PATIENT BEHAVIOUR HAS BEEN REPORTED, THIS CAUSE CANNOT BE EXCLUDED. HOWEVER, THE REPORTED POST-OPERATIVE TREATMENT ACCORDING TO THE STUDY REPORT DID NOT SHOW ANY CONSPICUOUSNESS. IMPAIRED DEVICE PERFORMANCE DUE TO PATIENT¿S MEDICAL CONDITIONS INFLUENCE THE APPLIED MECHANICAL OR BIOLOGICAL INPUTS TO THE DEVICES POSSIBLE, AS THE STUDY REPORT STATES THAT THE PATIENT'S BONE QUALITY IS SCLEROTIC. IMPAIRED DEVICE PERFORMANCE DUE TO EXTERNAL LOADING APPLIED TO THE SHOULDER, SUCH AS TRAUMA POSSIBLE, EVEN THOUGH, NO TRAUMA HAS BEEN REPORTED WITHIN THE STUDY REPORT, THIS CAUSE CANNOT BE EXCLUDED. ASEPTIC LOOSENING DUE TO LASER MARKING/ENGRAVING NOT READABLE IN NORMAL LIGHTING CONDITIONS LEADS TO USE OF WRONG IMPLANT NOT POSSIBLE, AS BASED ON THE X-RAY ANALYSIS A CORRECTLY SIZED IMPLANT HAS BEEN INSERTED. CONCLUSION SUMMARY: BASED ON THE MEDICAL RECORDS AND THE X-RAY ANALYSIS BY A HEALTH CARE PROFESSIONAL THE COMPLAINT COULD BE CONFIRMED. ACCORDING TO THE IMPLANTATION REPORT, DATED ON (B)(6) 2014, THE COMPONENTS WERE WELL SEATED AND WELL FIXED WITH GOOD ANATOMIC RESTORATION OF THE PROXIMAL HUMERUS. THE SHOULDER WAS CHECKED THROUGHOUT ALL RANGE OF MOTION WITH NO SIGNS OF IMPINGEMENT AND APPROPRIATE TENSION ON ALL SOFT TISSUES, 50% POSTERIOR TRANSLATION WITH GOOD BOUNCE BACK TO CENTER OF GLENOID, 25% INFERIOR TRANSLATION WITH GOOD BOUNCE BACK TO CENTER OF GLENOID, AND GOOD RANGE OF MOTION. FURTHER, THE REPORTED X-RAY FOLLOW-UP MENTIONED THE SIDUS TSA IMPLANT TO BE IN GOOD, STABLE POSITION, WELL FIXED IN BOTH GLENOID AND HUMERUS. NO SIGNS OF SHIFTING OR LOOSENING. NO SIGNS OF PERIPROSTHETIC FRACTURE, SUBLUXATION, OR DISLOCATION AND THE JOINT SPACE WELL REDUCED AT 6 WEEKS, 5 MONTHS, AT 12 MONTHS, AT 22 MONTHS AND 42 MONTHS. HOWEVER, THE 12 MONTHS AND 22 MONTHS FOLLOW-UP ADDITIONALLY STATED SOME CALCIFICATION AT THE INFERIOR POUCH. ACCORDING TO THE CRF REPORT THE PAIN SCORE AS WELL AS THE SUBJECT SHOULDER VALUE STEADILY IMPROVED FROM 2014 (PAIN: 9.4, SHOULDER VALUE: 40%) UNTIL 2018 (PAIN: 0.2 AND SHOULDER VALUE: 98%). FURTHER, TWO ADVERSE EVENTS WERE REPORTED. THE FIRST WAS REPORTED IN FEBRUARY 2015 AND CONSISTED OF CONTRACTURE. THE ADVERSE EVENT WAS TREATED BY MANIPULATION AND WAS REPORTED TO BE RESOLVED. THE SECOND ADVERSE EVENT WAS REPORTED IN MAY 2018 AND CONSISTED OF RADIOLUCENCY AROUND THE L GLENOID. THE CURRENT TREATMENT FOR THE SECOND ADVERSE EVENT IS PATIENT MONITORING. EARLY OR LATE LOOSENING OF COMPONENTS IS LISTED AS ADVERSE EVENT WITHIN THE APPLICABLE IFU. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FURTHER, BASED ON THE REVIEW OF THE MEDICAL DATA NO SYMPTOMS HAVE BEEN REPORTED IN REGARDS TO THE DETECTED RADIOLUCENCY. AS THE RADIOLUCENCY HAS ONLY BEEN REPORTED WITH RESPECT TO THE GLENOID, NO ADVERSE EVENT HAS BEEN IDENTIFIED WITH RESPECT TO THE SIDUS STEM-FREE HUMERAL ANCHOR AND THE HUMERAL HEAD. ACCORDING TO THE X-RAY ANALYSIS PERFORMED BY OUR HCP NO RADIOLOGICAL EVIDENCE OF ANY PATHOLOGICAL OSSEOUS STRUCTURAL LESIONS IN THE AREA OF THE GLENOID IMPLANT COMPONENT ON THESE AVAILABLE X-RAY IMAGES. SINCE THERE ARE NO RADIOGRAPHS FROM 2018, THE RADIOLUCENCY GRADE I, WHICH APPEARED TO BE 3.5 YEARS POSTOPERATIVELY IN APRIL 2018, CANNOT BE CONFIRMED. THEREFORE, BASED ON THE INVESTIGATION WE WERE NOT ABLE TO RECREATE THE REPORTED ISSUE. HOWEVER, RE-EVALUATION WILL TAKE PLACE WHENEVER NEW INFORMATION BECOMES AVAILABLE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2018-00600, 0009613350-2018-00609.
NO CHANGE TO INITIALLY REPORTED EVENT.
CONCOMITANT MEDICAL PRODUCTS: ITEM # 9904555130, ITEM NAME: SIDUS STEM-FREESHOULDER, HUMERAL ANCHOR,UNCEMENTED, LOT# 2711344, ITEM # 01.04214.400, ITEM NAME: ANATOMICAL SHOULDER, GLENOID, PEGGED, CEMENTED, L, LOT #2747148. THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E REF# 01.04212.400, A.S. HUMERAL HEAD D 40 H 14, K003801) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION AS IT IS STILL IMPLANTED. X-RAYS WERE PROVIDED AND WILL BE REVIEWED WITHIN INVESTIGATION. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00600. (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AS GLENOID SHOULDER ON THE LEFT SIDE AND GRADE 1 RADIOLUCENCY WAS NOTED DURING A FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428696 | SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 50-21 | N/A | HSD | ZIMMER GMBH | N/A | 2706769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |