BIOLOX DELTA, CERAMIC FEMORAL HEAD, S¸ 32/-3.5, TAPER 12/14

Report

Report Number: 0009613350-2018-00741
Event Type: Injury
Date Received: August 9, 2018
Date of Event: May 30, 2018
Report Date: December 28, 2018
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: NL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DISLOCATION. EVENT SUMMARY: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A BIOLOX DELTA, CERAMIC FEMORAL HEAD, AND EXPERIENCED 3.5 WEEKS POST IMPLANTATION TWICE A DISLOCATION. BOTH TIMES A CLOSED REDUCTION OF THE DISLOCATION WAS PERFORMED. REVIEW OF RECEIVED DATA 5 X-RAYS WERE RECVEIVED AND INVESTIGATED BY HCP. IN THE AVAILABLE PELVIS OVERVIEW FROM (B)(6) 2018 RECOGNIZABLE CEMENTLESS HIP ENDOPROSTHESIS WITH CORRECT STEM AND CUP POSITION WITHOUT ANY ABNORMALITIES. TWO AVAILABLE X-RAYS ( ONE IN LAUENSTEIN VIEW, ONE IN AP-VIEW) DATED 01.06.2018 SHOW A DISLOCATION OF A CEMENTLESS TOTAL HIP REPLACEMENT ON THE LEFT AND AN INCONSPICUOUS FITTED IMPLANT. TWO REPORTS IN DUTCH WERE RECEIVED AND REVIEWED BY HCP: - IMPLANTATION REPORT FROM (B)(6) 2018: REASON FOR SURGERY: COXARTHROSIS LEFT. INTERVENTION: TOTAL HIP REPLACEMENT. ALLOFIT ACETABULAR SHELL 56/KK, ALLOFIT LINER KK/32, M/L TAPER SIZE 11.0 EXTENDED OFFSET, BIOLOX DELTA HEAD (B)(6) LATERAL ACCESS TO THE HIP. CUP SIZE 56 PLACED IN NATURAL INCLINATION AND ANTEVERSION. AFTER TRIAL REDUCTION WITH FEMORAL SIZE 11 AND FEMORAL HEAD -3 NO DISLOCATION TENDENCY, THE LEGS ARE ABOUT THE SAME LENGTH, GOOD STABILITY WITHOUT CONTRACTURES. IMPLANTATION OF THE ROTATION-STABLE PROSTHESIS SIZE 11, HEAD SIZE -3. DEFINITIVE REPOSITIONING AFTER INSPECTION OF THE CUP. INTRAOPERATIVELY ON (B)(6) 2018 INCONSPICUOUS DESCRIBED IMPLANTATION OF A CEMENTLESS TOTAL HIP REPLACEMENT ON THE LEFT BY LATERAL ACCESS WITH PLACED CUP SIZE 56 IN NATURAL INCLINATION AND ANTEVERSION WITH GOOD STABILITY WITHOUT DISLOCATION TENDENCY OR CONTRACTURES AFTER TRIAL REDUCTION WITH THE FINALLY USED PROSTHESIS SIZE. - 23 DAYS LATER ON (B)(6) 2018 DISLOCATION OF THE LEFT HIP WHILE SITTING WITH CROSSED LEGS AND SUBSEQUENT REDUCTION IN SHORT ANESTHESIA. - EMERGENCY RECORD: ON THE FOLLOWING DAY (B)(6) 2018 AGAIN DISLOCATION OF THE HIP UNDER A SLIGHTLY DESCRIBED MOVEMENT WITH RENEWED REDUCTION IN SHORT ANESTHESIA. - SUMMARY: DUE TO THE RISK OF DISLOCATION OF THE HIP JOINT, NORMALLY THERE SHOULD BE NO CROSSOVER OF THE LEGS FOR ABOUT 2 MONTHS AFTER TOTAL HIP REPLACEMENT. IN THE PRESENT CASE INCONSPICUOUSLY DESCRIBED IMPLANTATION OF A CEMENTLESS HIP ENDOPROSTHESIS ON (B)(6)2018 WITH INTRAOPERATIVELY MENTIONED GOOD STABILITY WITHOUT DISLOCATION TENDENCY OR CONTRACTURES AFTER TRIAL REDUCTION WITH THE FINALLY USED PROSTHESIS SIZE. ALMOST 3 WEEKS LATER, THE DISLOCATION OCCURRED WHILE SITTING WITH CROSSED LEGS WHICH CAN BE JUDGED AS ADEQUATE TRAUMA. THEREFORE, THIS SITTING WITH CROSSED LEGS JUST 3 WEEKS AFTER IMPLANTATION CAN BE CONSIDERED AS THE PREDOMINANT PROBABLE CAUSE OF HIP DISLOCATION. FROM THE PRESENT FILES NO EVIDENCE CAN BE FOUND ON PATIENT- AND/OR IMPLANT-RELATED RISK FACTORS FOR A POSSIBLE OCCURRENCE OF DISLOCATION OF THE TOTAL HIP REPLACEMENT. ACCORDING TO EXPERIENCE, AFTER AN INITIAL DISLOCATION, AN INCREASED RE-DISLOCATION RATE CAN BE ASSUMED, AS DESCRIBED IN THE PRESENT CASE DEVICES ANALYSIS NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS, ACCORDING TO THE INFORMATION RECEIVED THE DEVICE IS STILL IN VIVO. REVIEW OF PRODUCT DOCUMENTATION THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW FOR THE BIOLOX HEAD: - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, DISLOCATION, SUBLUXATION, ABRASIVE WEAR DUE TO INADEQUATE HEAD DESIGN LEADS TO IMPINGEMENT; LIMITED RANGE OF MOTION NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD,POSTOPERATIVE TISSUE REACTION, METALOSIS, DISLOCATION,DISSOCIATION,ASEPTIC LOOSENING OF STEM, OSTEOLYSIS DUE TO INSUFFICIENT CONNECTION STRENGTH / MICROMOTION LEADING TO WEAR IN TAPER CONNECTION BETWEEN STEM AND HEAD NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH INSUFFICIENT CONNECTION STRENGTH/MICROMOTION WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - 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 => POSSIBLE, DEVICE IS NOT AT HAND FOR VISUAL EXAMINATION, THE CONDITION OF THE DEVICES IS UNKNOWN. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED WITH CERTAINTY. - POSTOPERATIVE TISSUE REACTION, DISLOCATION, ASEPTIC LOOSENING OF STEM, INCREASED WEAR,OSTEOLYSIS DUE TO INCREASED FRICTION FOR CERAMICON- POLY OR CERAMIC-ON-CERAMIC BEARING LEADING TO LOOSENING OF COMPONENTS OR INCREASED WEAR => POSSIBLE, DEVICE IS NOT AT HAND FOR VISUAL EXAMINATION, THE CONDITION OF THE DEVICES IS UNKNOWN. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED WITH CERTAINTY. - 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 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). NOT POSSIBLE -> X-RAYS REVIEW CONFIRMED THE GOOD POSITIONING OF THE IMPLANTS. - 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 -> X-RAYS REVIEW CONFIRMED THE GOOD POSITIONING OF THE IMPLANTS. - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, IMPLANT BREAKAGE, CORROSION, METALOSIS, 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, DEVICES ARE NOT AT HAND FOR VISUAL EXAMINATION, THE CONDITION OF THE DEVICES IS UNKNOWN. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED WITH CERTAINTY. - DISLOCATION, SUBLUXATION, ABRASIVE WEAR, LEG LENGTH DISCREPANCY,IMPINGEMENT,LIMITED RANGE OF MOTION DUE TO SOFT TISSUE LAXITY => POSSIBLE, NO INFORMATION ABOUT PATIENT TISSUE CONDITION AVAILABLE. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED WITH CERTAINTY. - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, ABRASIVE WEAR,FRETTING CORROSION,DISLOCATION, DISSOCIATION DUE TO EXPLANTED CERAMIC HEAD IS REUSED WITH THE SAME OR NEW FEMORAL STEM NOT POSSIBLE -> NO INFORMATION RECEIVED, THAT AN EXPLANTED DEVICE WAS REUSED. - 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 -> THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT COMBINATION USED IS ALLOWED. - IMPLANT BREAKAGE, DISLOCATION DUE TO INAPPROPRIATE ADVICE BY SURGEON TO INFORM PATIENT ON POSTOPERATIVE ACTIVITIES AND LIMITS. => POSSIBLE, SURGEON REHABILITATION ADVICE TO PATIENT IS UNKNOWN, NO REPORT RECEIVED. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. CONCLUSION SUMMARY IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A BIOLOX DELTA, CERAMIC FEMORAL HEAD, AND EXPERIENCED 3.5 WEEKS POST IMPLANTATION TWICE A DISLOCATION. BOTH TIMES A CLOSED REDUCTION OF THE DISLOCATION WAS PERFORMED. IT WAS FOUND, THAT THE FIRST DISLOCATION HAS MOST LIKELY OCCURRED, WHILE THE PATIENT WAS SITTING WITH CROSSED LEGS. REVIEW OF THE X-RAYS REVEALED A GOOD POSITIONING OF THE IMPLANTS. DUE TO THE RISK OF DISLOCATION OF THE HIP JOINT, IT IS PROPOSED THAT THERE SHOULD BE NO CROSSOVER OF THE LEGS FOR ABOUT 2 MONTHS AFTER TOTAL HIP REPLACEMENT. THIS MOVEMENT CAN BE CONSIDERED AS AN ADEQUATE TRAUMA AND HAS MOST LIKELY CAUSED THE HIP DISLOCATION. ACCORDING TO EXPERIENCE, AFTER AN INITIAL DISLOCATION, AN INCREASED RE-DISLOCATION RATE CAN BE ASSUMED, WHICH HAS MOST LIKELY CONTRIBUTED TO THE SECOND DISLOCATION. FROM THE AVAILABLE DATA, NO EVIDENCE CAN BE FOUND ON PATIENT- AND/OR IMPLANT-RELATED RISK FACTORS FOR A POSSIBLE OCCURRENCE OF DISLOCATION OF THE TOTAL HIP REPLACEMENT. 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).

Description of Event or Problem · 0

NO CHANGE TO PREVIOUSLY REPORTED EVENT.

Additional Manufacturer Narrative · 1

UDI#: (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES DETAIL OF PRODUCT: ASSOCIATED ITEM NUMBER: 00000004247, ITEM NAME: ALLOFIT ALLOCLASSIC SHL 56/KK, LOT #: 2894030. ASSOCIATED ITEM NUMBER: 00771101120, ITEM NAME: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 11 EXTENDED OFFSET, LOT #: 63627068. ASSOCIATED ITEM NUMBER: 0100013411, ITEM NAME: DURASUL, ALPHA INSERT, KK/32, LOT #: 2886064. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: 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).

Description of Event or Problem · 1

IT WAS REPORTED THAT 3.5 WEEKS AFTER THE IMPLANT THE HIP WAS DISLOCATED AND NEEDED TO BE RE-POSITIONED MANUALLY BY THE SURGEON.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
607602	BIOLOX DELTA, CERAMIC FEMORAL HEAD, S¸ 32/-3.5, TAPER 12/14	ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS	LZO	ZIMMER GMBH	N/A	2927575

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R