SULOX-HD 32 M 12/14
Report
- Report Number
- 0009613350-2019-00243
- Event Type
- Injury
- Date Received
- April 23, 2019
- Date of Event
- November 12, 2018
- Report Date
- May 31, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE HISTORY RECORDS: REF:01.00013.410 ; LOT:2956974, YIELD:60, DELIVERED:59, SCRAPPED:1, REASON FOR SCRAPPING: FOREIGN INCLUSION. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF:4246 ; LOT: 2957634, YIELD:50, DELIVERED:49, SCRAPPED:1, REASON FOR SCRAPPING: DROPPED PRODUCT. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF:12.00.39-100 ; LOT:2959825, YIELD:48, DELIVERED:46, SCRAPPED:2, 1 PARTS SCRAPPED DUE TO CONE 12/14 DIAMETER IS TOO SMALL, 1 PARTS SCRAPPED DUE TO SURFACE AREA OF THE CONE DAMAGED. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF:17.32.06 ; LOT:2946709, YIELD:100, DELIVERED:100, SCRAPPED:0. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DISLOCATION OF IMPLANT. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A DURASUL INSERT ON (B)(6) 2018 AND UNDERWENT REVISION ON (B)(6) 2018 DUE TO DISLOCATION OF THE DURASUL INLAY. CUP AND FEMORAL HEAD WERE ALSO REVISED. PATIENT HAD NOT EXPERIENCED A FALL. REVIEW OF RECEIVED DATA: ONE CONSULATION LETTER HAS BEEN RECEIVED WHICH IS DATED FEBRUARY 02, 2018 ¿ JULY 19, 2018. DIAGNOSIS: LEFT SIDE COXARTHROSIS. CONSULTATION FOR TOTAL HIP REPLACEMENT. IMPLANTATION REPORT: THE IMPLANTATION REPORT DATED OCTOBER 12, 2018 HAS BEEN RECEIVED. DIAGNOSIS: COXARTHROSIS. INTERVENTION: IMPLANTATION OF THE TOTAL HIP IMPLANT LEFT. PROCEDURE: UNSPECIFICALLY DESCRIBED IMPLANTATION OF A CEMENTED LATERALIZED MÜLLER STRAIGHT STEM. A 54ER ALLOFIT CUP IS WELL CEMENTED AFTER STEPWISE MILLING, WITH ABOUT 45 ° INCLINATION AND 15-20 ° ANTEVERSION. AFTER IMPLANTATION OF THE STEM AND CUP THERE IS GOOD MUSCLE TENSION WITHOUT DISLOCATION TENDENCY UNSURED WITH FINAL IMAGE INTENSIFIER CONTROL. REVISION REPORT: THE REVISION REPORT DATED NOV 13, 2018 HAS BEEN RECEIVED. DIAGNOSIS: INLAY DISLOCATION OF THE ALLOFIT CUP. INTERVENTION: REVISION OF CUP AND HUMERAL HEAD INTRAOPERATIVELY DESCRIBED INVERSION OF THE INLAY WITH ITS OPENING BEING LATERALLY. WITH THE DISLOCATION SPOON, THE INLAY CAN BE LIFTED AND REMOVED. AFTER CAREFULLY LOOSENING THE LATERAL EDGE OF THE CUP WITH THE CHISEL, THE CUP CAN BE REMOVED AFTER DISLOCATION WITH A SPOON. AFTER APPROPRIATE MILLING, AN ALLOFIT-S CUP IS HAMMERED IN WITH 40 ° INCLINATION AND 20 ° ANTEVERSION ANGLE. DUE TO THE GOOD FIT, NO ADDITIONAL SCREWING ARE NECESSARY. AFTER REPOSITION WITH A 32 MM L-HEAD ABSOLUTELY STABLE LUXATION CONDITIONS WITH SUBSEQUENTLY WELL-DESCRIBED PROSTHESIS SEAT IN THE IMAGE INTENSIFIER CONTROL. A LARGE AMOUNT OF X-RAYS HAVE BEEN RECEIVED. THE RELEVANT ONES HAVE BEEN REVIEWED BY AN HCP: 19.07.2018: PELVIS OVERVIEW (PREOPERATIVELY PLANNING): MEASURED PLANNED CUP INCLINATION ANGLE OF APPROXIMATELY 40 °. (B)(6) 2018: LEFT HIP (INTRAOPERATIVELY IMAGE INTENSIFIER): INDICATED RELATIVELY FLAT CUP INCLINATION ANGLE, OTHERWISE NO ABNORMALITIES. (B)(6) 2018: PELVIS OVERVIEW, RIGHT HIP AP-/LAUENSTEIN VIEW: EXTREMELY FLAT ANGLE, OWN MEASUREMENT APPROXIMATELY 28 ° (B)(6) 2018: PELVIS OVERVIEW, RIGHT HIP LAUENSTEIN-VIEW: DECENTERING OF THE FEMORAL HEAD (BLACK ARROW). COMPARED TO THE PREVIOUS X-RAY DECREASED CUP INCLINATION ANGLE WITH APPROXIMATELY 21°. (B)(6) 2018: CT PELVIS: CUP INCLINATION ANGLE APPROXIMATELY 23°. SUMMARY: ON (B)(6) 2018 IMPLANTATION OF A WELL FIXED CEMENTED LATERALIZED MÜLLER STRAIGHT STEM AND 54 ALLOFIT CUP WITH DURASUL INSERT IN ABOUT 45 ° INCLINATION AND 15-20 ° ANTEVERSION. THE AVAILABLE RADIOLOGICAL PLANNING SHOWS A DRAWN INCLINATION ANGLE OF APPROXIMATELY 40 °. THE PRESENT INTRAOPERATIVE IMAGE INTENSIFIER CONTROL SHOWS A RELATIVELY FLAT CUP INCLINATION ANGLE. 5 DAYS AFTER IMPLANTATION, A CUP INCLINATION ANGLE OF 26.29 ° IS PLOTTED ON (B)(6) 2018 ON THE PRESENT PELVIC OVERVIEW. THE OWN MEASUREMENT RESULTS IN AN ANGLE OF APPROXIMATELY 28 °. 4 WEEKS LATER ON (B)(6) 2018 RADIOLOGICALLY RECOGNIZABLE DECENTERING OF THE FEMORAL HEAD WITH DECREASED CUP INCLINATION ANGLE OF APPROXIMATELY 21°. INTRAOPERATIVELY, AN INSERT IS DESCRIBED IN THE SUBSEQUENT REVISION SURGERY ON (B)(6) 2018, WHICH HAS BEEN TURNED LATERALLY WITH THE OPENING. ACCORDING TO THE AVAILABLE INFORMATION, NO TRAUMA OCCURRED. CONCLUSION: BASED ON THE AVAILABLE MEDICAL FINDINGS, THE CAUSE FOR THE DISLOCATION OF THE INLAY CANNOT BE ASSESSED WITH CERTAINTY. WHETHER POSSIBLY A FAULTY FITTING HAS LED TO THE TIMELY DISLOCATION OF THE INSERT, CANNOT BE ASSESSED BASED ON THE AVAILABLE MEDICAL FINDINGS AND INFORMATION. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING SAP RMW : LOSS OF INSERT-SHELL CONNECTION, COMPONENT LOOSENING, DISLOCATION DUE TO INSUFFICIENT INSERT STABILITY DUE TO DESIGN (SNAP GEOMETRY). NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. DEGRADATION DAMAGE LEADS TO IMPAIRMENT OF IMPLANT PARTS OR FRACTURE DUE TO GENERAL DEGRADATION (E.G. DECREASE OF MOLECULAR WEIGHT, MECHANICAL PROPERTIES) OF IMPLANT DEVICE. NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. DAMAGED DEVICE IS IMPLANTED DUE TO WRONG HANDLING OF DEVICE IN OR E.G. DUE TO MISSING / UNCLEAR INFORMATION. NOT POSSIBLE, ALL INFORMATION CONCERNING THE HANDLING OF THE DEVICE IS GIVEN IN IFU (SECTION WARNINGS). INCOMPLETE INSERT FIXATION IN SHELL LEADING TO POSTOP COMPLICATIONS DUE TO EXCESSIVE IMPACTION FORCE. POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. IMPLANT DISLOCATION / LOOSENING / FRACTURE DUE TO SELECTION OF WRONG COMPONENTS. NOT POSSIBLE, THE IMPLANTS WERE FOUND TO BE COMPATIBLE. INCOMPLETE INSERT FIXATION IN SHELL LEADING TO POSTOP COMPLICATIONS (INSERT DISLOCATION, LOOSENING, FRACTURE DUE TO WRONG OR INCOMPLETE INSPECTION. POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. IMPLANT BREAKAGE, INCREASED WEAR (EG. M-O-M ARTICULATION), LOSS OF CONNECTION BETWEEN COMPONENTS DUE TO INSUFFICIENT DESCRIPTION OF SURGICAL PROCESS LEADS TO INTRAOPERATIVE ERRORS OR MISUSE OF IMPLANT OUTSIDE OF ITS SCOPE (IMPLANT PARTICLES REMAIN IN BODY AFTER REVISION ). NOT POSSIBLE, ALL INFORMATION CONCERNING THE IMPLANTATION OF THE DEVICE IS GIVEN IN THE SURGICAL TECHNIQUE ALLOFIT CUP AND IN THE IFU (SECTION INDICATIONS, WARNINGS, INTRAOPERATIVE). CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF THE DURASUL INLAY AFTER ONE MONTH IN VIVO. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NEITHER THE DEVICE NOR PHOTOS OF THE EXPLANTED PRODUCT WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE X-RAY ANALYSIS SHOWED THAT THE INCLINATION ANGLE OF THE CUP IS FIVE DAYS AFTER IMPLANTATION EXTREMELY LOW. HOWEVER IT REMAINS UNKNOWN WHETHER THIS MIGHT HAVE CONTRIBUTED TO THE DISLOCATION OF THE INLAY. MOREOVER IT REMAINS UNKNOWN, WHETHER THERE MIGHT HAVE BEEN IN INCOMPLETE INLAY FIXATION IN THE SHELL AFTER IMPLANTATION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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 - 01225 - 3.
INVESTIGATION RESULTS HAVE BEEN UPDATED.
THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K923808. THE MANUFACTURER RECEIVED DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: SULOX-HD 32 M 12/14, ITEM#: 17.32.06, LOT#: 2946709; ITEM NAME: ALLOFIT ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, ITEM#: 4246, LOT#: 2957634; ITEM NAME: ORIGINAL M.E. MUELLER, STEM, PT-10, STRAIGHT, ITEM#: 120039100, LOT#: 2959825. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2018 - 01225 - 2.
IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY ONE MONTHS POST IMPLANTATION DUE TO DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333872 | SULOX-HD 32 M 12/14 | N/A | LZO | ZIMMER GMBH | N/A | 2946709 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |