BIOLOX DELTA, CERAMIC FEMORAL HEAD, M¸ 28/0, TAPER 12/14
Report
- Report Number
- 0009613350-2018-01078
- Event Type
- Injury
- Date Received
- October 17, 2018
- Date of Event
- September 24, 2013
- Report Date
- March 29, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- PK071535
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. NEW INFORMATION RECEIVED: - LOT# OF STEM UPDATED. - DHR-REVIEW PERFORMED. AN INVESTIGATION OF THE CASE WAS STARTED AND THE INTERIM RESULTS HAVE BEEN MADE AVAILABLE: DHR REVIEW: REF: (B)(4). LOT: 2683287 - YIELD: 145 - DELIVERED: 145 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF:(B)(4). LOT: 2702868 - YIELD: 50 - DELIVERED: 50 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF#:(B)(4). LOT#: 4020447 - YIELD: 24 - DELIVERED: 24 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS(B)(4). NOTE: THE FOLLOWING CASES ARE ASSOCIATED WITH THIS EVENT: (B)(4).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: DHR REVIEW: 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 EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2013 THE PATIENT RECEIVED LEFT THR AND SUDDENLY THE NEXT DAY ON (B)(6) 2013 HE HAD AN LUXATION OF THE PROSTHESIS, MAYBE IN THE MOMENT OF THE TRANSFER OF THE PATIENT FROM THE BED TO THE SOFA. HE GOT A REDUCTION UNDER GENERAL ANESTHESIA ON THE SAME DAY. ON (B)(6) 2013, THE PATIENT SUFFERED A SECOND LUXATION OF THE PROSTHESIS AND WENT TO EMERGENCY AT THE HOSPITAL, WHICH WAS AGAIN TREATED UNDER GENERAL ANESTHESIA ON (B)(6) 2013. FINALLY, PATIENT UNDERWENT REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2013 DUE TO INSTABILITY AND RECURRENT DISLOCATIONS. THIS COMPLAINT COVERS THE REVISION SURGERY DUE TO DISLOCATION WHICH TOOK PLACE ON (B)(6) 2013. REVIEW OF RECEIVED DATA: ALL THE X-RAYS RECEIVED ARE UNDATED WHICH MADE THE ANALYSIS OF THE COMPLAINT DIFFICULT. THE X-RAYS WHICH HAVE THE FEMORAL HEAD DISLOCATED FROM THE ACETABULAR SOCKET SHOWS THAT THE ACETABULAR CUP HAS 41 INCLINATION ANGLE WHICH IS IN THE LIMITS, HOWEVER, IT ALSO HAS QUITE MUCH ANTEVERSION ( BIGGER THAN 10-15 WHICH IS THE SUGGESTED ANTEVERSION ANGLE RANGE FOR ALLOFIT CUPS). STEM DOES APPEAR TO HAVE NO POSITIONAL PROBLEMS. PRIMARY SURGERY REPORT DATED (B)(6) 2013 IS REVIEWED AND SHOW DO NOT ANY ABNORMALITIES STATED DURING THE SURGERY. REVISION SURGERY REPORT DATED (B)(6) 2013: INDICATION: PATIENT WHO EXHIBITS EARLY INSTABILITY WITH PREVIOUS DISLOCATIONS OF A TOTAL LEFT HIP PROSTHESIS SET UP 4 WEEKS AGO ON THE LEFT WITH CT SCAN THAT SHOWS NO POSITIONAL ABNORMALITY ON THE FEMORAL COMPONENT, WHICH SHOWS AN ACETABULAR CUP THAT HAS AN ANTEVERSION 25-30 . IN ADDITION LOWER LIMB LEFT + 5 MM = RIGHT LOWER LIMB. DECISION OF SURGICAL REVISION IS MADE. - PROCEDURE: UNDER GENERAL ANESTHESIA, RIGHT LATERAL DECUBITUS RESUMPTION OF THE POSTEROLATERAL APPROACH. HEALTHY APPEARANCE MACROSCOPICALLY. BACTERIOLOGICAL AND ANAPATHIC SAMPLING. OPENING OF THE CAPSULE WHICH HAD BEEN RE-SUTURED AS WELL AS PELVI-TROCHANTERIENS WHICH ARE IN A GOOD POSITION. CUP, LINER AND HEAD WERE REVISED AND GOOD STABILITY WAS ACHIEVED WITH THE REDUCED PROSTHESIS. SIZE 32 BIOLOX HEAD AND SIZE 54 SHELL WERE REPLACED. NO ABNORMALITES OBSERVED. 3. DEVICES ANALYSIS NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. 4. REVIEW OF PRODUCT DOCUMENTATION - THE COMPATIBILITY CHECK WAS PERFORMED FROM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. - SURGICAL TECHNIQUE SAP INDICATES ON PAGE 3 UNDER SECTION PREOPERATIVE PLANNING THAT THE INCLINATION OF THE SHELL SHOULD FORM AN ANGLE OF 40¿ 45 TO THE PELVIC HORIZONTAL LINE. AND THE SHELL SHOULD BE PLACED IN AN ANTEVERSION OF 10 ¿ 15 INTRAOPERATIVELY. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING SAP RMW : - POSTOPERATIVE TISSUE REACTION, METALOSIS, DISLOCATION, ASEPTIC LOOSENING OF STEM, OSTEOLYSIS DUE TO PE, CERAMIC OR METAL PARTICLE RELEASE FROM ARTICULATION (HEAD AND INLAY) OR TAPER (HEAD AND STEM) CONNECTION DUE TO WEAR NOT POSSIBLE NOT SUCH ISSUE REPORTED OR OBSERVED. - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, DISLOCATION, SUBLUXATION, DISSOCIATION, ABRASIVE WEAR, LIMITED ROM, IMPINGEMENT DUE TO INADEQUATE HEAD AND/OR ADAPTER DESIGN LEADS TO IMPINGEMENT (COMPONENT TO BONE) WITH STEM NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, DISLOCATION, SUBLUXATION, ABRASIVE WEAR DUE TO IMPINGEMENT (COMPONENT TO BONE, COMPONENT TO COMPONENT, COMPONENT TO SOFT TISSUE) DUE TO MALPOSITION OF COMPONENTS (STEM, HEAD, CUP) => POSSIBLE, HIGHER ANTEVERSION ANGLE THAN 10-15 AS SUGGESTED IN THE SURGICAL TECHNIQUE MOST POSSIBLY LED TO DISLOCATION OF HEAD. DISLOCATION, SUBLUXATION, LEG LENGTH DISCREPANCY, ASEPTIC LOOSENING OF COMPONENTS DUE TO SELECTION OF WRONG COMPONENTS (E.G. WRONG SIZE OF HEAD DIAMETER AND/OR OFFSET) NOT POSSIBLE CORRECT COMPONENTS WERE SELECTED. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, IMPLANT BREAKAGE, CORROSION, METALLOSIS, DISLOCATION, SUBLUXATION, ABRASIVE WEAR DUE TO HEAD IS IMPLANTED ON A DAMAGED STEM TAPER; USAGE OF A WET AND/OR UNCLEAN STEM AND/OR HEAD TAPER (PARTICLES BETWEEN STEM TAPER AND BALL HEAD TAPER) POSSIBLE, CANT BE CONFIRMED, THEREFORE CANNOT BE EXCLUDED. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, ABRASIVE WEAR, FRETTING CORROSION, DISLOCATION, DISSOCIATION, IMPLANT FRACTURE, SOFT TISSUE IMPINGEMENT DUE TO INAPPROPRIATE ASSEMBLING OF HEAD WITH STEM (E.G. INSUFFICIENT IMPACTION FORCE AND/ OR OFF AXIS IMPACTION, TORQUE ON HEAD) POSSIBLE, CANT BE CONFIRMED, THEREFORE CANNOT BE EXCLUDED. DISLOCATION, SUBLUXATION, ABRASIVE WEAR, LEG LENGTH DISCREPANCY, IMPINGEMENT, LIMITED RANGE OF MOTION DUE TO SOFT TISSUE LAXITY POSSIBLE, IT IS NOT REPORTED, HOWEVER CANNOT BE EXCLUDED. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, ABRASIVE WEAR, DISLOCATION, SUBLUXATION, FRACTURE OF HEAD, LEG LENGTH DISCREPANCY DUE TO OFF LABEL USE; WRONG COMBINATION OF COMPONENTS USED; COMBINATION WITH COMPETITOR PRODUCTS NOT POSSIBLE -> PRODUCT COMBINATION WAS ALLOWED. DISLOCATION, SUBLUXATION, ASEPTIC LOOSENING DUE TO INAPPROPRIATE INFORMATION ON PACKAGING LABEL OR NOT LEGIBLE PACKAGING LABEL LEADS TO INCORRECT USE OF IMPLANT NOT POSSIBLE IFU (CHAPTERS: INDICATIONS AND WARNINGS) PROVIDES THE NECESSARY AND APPROPRIATE INFORMATION. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, ABRASIVE WEAR, DISLOCATION, SUBLUXATION, FRACTURE OF HEAD DUE TO LASER MARKING NOT READABLE IN NORMAL LIGHTING CONDITIONS LEADS TO USE OF WRONG HEAD NOT POSSIBLE DHR OF THE PRODUCT SHOWS RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. IMPLANT BREAKAGE, DISLOCATION DUE TO INAPPROPRIATE ADVICE BY SURGEON TO INFORM PATIENT ON POSTOPERATIVE ACTIVITIES AND LIMITS. POSSIBLE, CANT BE CONFIRMED, THEREFORE CANNOT BE EXCLUDED. CONCLUSION: CONCLUSION SUMMARY PATIENT UNDERWENT REVISION SURGERY AFTER RECURRENT DISLOCATIONS 22 DAYS POST-OP. REVISION SURGICAL NOTES AND X-RAYS SUGGEST THAT THE ACETABULAR SHELL HAD ABNORMAL ANTEVERSION ANGLE (25-30 AS STATED IN THE REVISION REPORT), WHEREAS THE ANTEVERSION ANGLE RANGE SUGGESTED IN THE SURGICAL TECHNIQUE IS 10-15. RAW MATERIAL CERTIFICATE CONFIRMS THAT THE DEVICE WAS MANUFACTURED ACCORDING TO THE MATERIAL SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PRODUCT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. THE MOST LIKELY REASON OF THE EVENT IS THE MALPOSITION OF THE CUP (ABNORMAL ANTEVERSION ANGLE), SURGEON NOT FOLLOWING THE SURGICAL TECHNIQUE. OTHER POSSIBLE REASONS LEADING TO THE DISLOCATION EVENT COULD INCLUDE IMPLANTATION ON A DAMAGED STEM TAPER; USAGE OF A WET AND/OR UNCLEAN STEM AND/OR HEAD TAPER (PARTICLES BETWEEN STEM TAPER AND BALL HEAD TAPER), INAPPROPRIATE ASSEMBLING OF HEAD WITH STEM (E.G. INSUFFICIENT IMPACTION FORCE AND/ OR OFF AXIS IMPACTION, TORQUE ON HEAD), SOFT TISSUE LAXITY AND PATIENT RELATED ISSUE (EXCESSIVE MOVEMENT) HOWEVER, 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).
NO NEW INFORMATION.
PLEASE REFER TO REPORT 0009613350-2018-01078.
CONCOMITANT MEDICAL DEVICES - LINER NEUTRAL 28 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL, CATALOG NO# 00875101028; LOT NO# 62325521. ALLOFIT IT ALLOCLASSIC, SHELL FOR ACETABULUM, UNCEMENTED, 52/II, CATALOG NO# 00875505200; LOT NO# 2702868. AVENIR MALLER, STEM, LATERAL, UNCEMENTED, HA, 3, TAPER 12/14, CATALOG NO# 0106010103; LOT NO# UNKNOWN. THERAPY DATE: (B)(6) 2013. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED 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. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).
PATIENT WAS IMPLANTED ON LEFT SIDE AND UNDERWENT REVISION DUE TO INSTABILITY AND DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 815153 | BIOLOX DELTA, CERAMIC FEMORAL HEAD, M¸ 28/0, TAPER 12/14 | BIOLOX DELTA, CERAMIC FEMORAL HEAD | LZO | ZIMMER GMBH | N/A | 2683287 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |