BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14
Report
- Report Number
- 0009613350-2019-00334
- Event Type
- Injury
- Date Received
- May 28, 2019
- Date of Event
- March 7, 2017
- Report Date
- September 23, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- UDI-DI
- 00889024430327
- PMA / PMN Number
- K071535
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- 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: NEW INFORMATION RECEIVED FROM SURGEON. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2019 - 00335 - 1.
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: PAIN, LEG LENGTH DISCREPANY, RADIOLUCENCY EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TOTAL HIP PROTHESIS ON (B)(6) 2016 ON THE RIGHT HIP SIDE. DURING THE CLINICAL STUDY AND REGULAR POST-OP EXAMINATION IT WAS OBSERVED THAT PATIENT HAD RADIOLUCENCY; PAIN AND LEG LENGTH DISCREPANCY (LEFT SHORT BY 1CM). THE PAIN WOULD BE IN IN THE LUMBAR SPINE (LWS), THROUGH THE GLUTEUS AREA AND UNTIL THE RIGHT KNEE. MOREOVER IT IS INDICATED, THAT AFTER ANALYZING ALL CONDITIONS OF DISCOMFORT AND A CONVERSATION WITH THE OPERATING SURGEON, THE TEP RIGHT SIDE IS NOT CONSIDERED THE CAUSE OF THE PAIN /DISCOMFORT. THE LUMBAR SPINE PROBLEM OF THE PATIENT IS IN DOCTOR¿S OPINION THE ADVERSE EVENT TO BE CONSIDERED. AFTER TREATING THE LUMBAR PROBLEM, THE PATIENT REPORTED A CLEAR DISCOMFORT IMPROVEMENT OF 80%. REVIEW OF RECEIVED DATA: CLINICAL STUDY DOCUMENT: OPERATIVE INFORMATION (B)(6)2016: SURGICAL APPROACH: ANTERIOR LATERAL. CAPSULE WAS NOT REPAIRED. NO INTRAOPERATIVE ADVERSE EVENTS. RADIOGRAPHIC EVALUATION 1&2 (B)(6) 2016: INCLINATION OF CUP (ANGLE):45 DEGREES, NEUTRAL VERSION. NO CUP MIGRATION, NO RADIOLUCENCY, NO OSTEOLYSIS. NEUTRAL A/P AND LATERAL STEM POSITION, NO STEM SUBSIDENCE, NO RADIOLUCENCY, NO OSTEOLYSIS. 1 YEAR FOLLOW-UP (B)(6) 2017: PATIENT DID NOT TAKE ANY PAIN, OR ANTIBIOTIC MEDICATION. NO LEG LENGTH DISCREPANCY. NO CHANGES IN IMPLANT POSITIONING NOTED. FEMORAL SIDE: A/P VIEW: 1MM RADIOLUCENCY BETWEEN PROSTHESIS AND BONE INTERFACE IN ZONE 1. PATIENT REPORTED MODERATE PAIN AND DISCOMFORT IN THE EUROQOL QUESTIONNAIRE. NO PAIN INDICATED IN HARRIS HIP SCORE. MILD PAIN REPORTED IN OXFORD HIP SCORE FOR THE LAST 4 WEEKS. 3 YEAR FOLLOW-UP (B)(6) 2019: PATIENT DID NOT TAKE ANY PAIN, OR ANTIBIOTIC MEDICATION. LEG LENGTH DISCREPANCY OF 1CM NOTED: LEFT SHORT. NO ADVERSE EVENTS. FEMORAL SIDE: A/P VIEW: 1MM RADIOLUCENCY BETWEEN PROSTHESIS AND BONE INTERFACE IN ZONE 1, 2, 6 AND 7. LATERAL VIEW: 1MM RADIOLUCENCY BETWEEN PROSTHESIS AND BONE INTERFACE IN ZONE 1. PATIENT REPORTED MODERATE PAIN AND DISCOMFORT IN THE EUROQOL QUESTIONNAIRE. MODERATE PAIN INDICATED IN HARRIS HIP SCORE. SEVERE PAIN REPORTED IN OXFORD HIP SCORE FOR THE LAST 4 WEEKS. X-RAYS: 7 X-RAYS FROM THE HIP JOINT AS WELL AS TWO FROM THE SPINE HAVE BEEN RECEIVED. MOREOVER, AN MRT FROM THE HIP (DATED (B)(6) 2019) AS WELL AS FROM THE SPINE (DATED (B)(6) 2019) HAVE BEEN RECEIVED. THE X-RAYS HAVE BEEN REVIEWED BY AN HCP (DR. (B)(6) (B)(6) 2016: PELVIS OVERVIEW: CUP INCLINATION ANGLE APPROXIMATELY 40 DEGREES, INCONSPICUOUS POSITION OF THE STEM. NO SIGNS OF LOOSENING. (B)(6) 2016: PELVIS OVERVIEW: COMPARED TO THE PREVIOUS X-RAY FROM (B)(6)2016 UNCHANGED CUP POSITION. COMPARED TO THE PREVIOUS X-RAY FROM (B)(6)2016 NOTICEABLE RADIOLUCENT LINE (APPROXIMATELY ONE X-RAY-MILLIMETER) IN THE AREA OF THE PROXIMAL PART OF THE STEM LATERAL AND MEDIAL. IN THE AREA OF THE ACETABULUM ROOF AT THE INTERFACE BETWEEN CUP AND BONE A SMALL RADIOLUCENT LINE IS VISIBLE. RIGHT HIP LATERAL: ALSO IN LATERAL-VIEW RECOGNIZABLE RADIOLUCENT LINE PROXIMAL. (B)(6) 2017: PELVIS OVERVIEW: COMPARED TO THE PREVIOUS X-RAYS NEARLY UNCHANGED POSITION OF THE CUP. COMPARED TO THE PREVIOUS X-RAY FROM (B)(6)2016 INCREASE OF THE RADIOLUCENT LINE LATERAL AND MEDIAL. UNCHANGED SMALL RADIOLUCENT LINE. RIGHT HIP LATERAL: ALSO IN THE LATERAL VIEW RECOGNIZABLE SLIGHT INCREASE OF THE RADIOLUCENT LINE PROXIMAL ANTEROLATERAL. (B)(6) 2019: PELVIS OVERVIEW: COMPARED TO THE PREVIOUS X-RAYS UNCHANGED POSITION OF THE CUP. COMPARED TO THE PREVIOUS X-RAY FROM (B)(6)2017 A SLIGHT WIDENING OF THE RADIOLUCENT LINE PROXIMAL LATERAL AND MEDIAL. UNCHANGED SMALL RADIOLUCENT LINE AT THE ACETABULUM ROOF. RIGHT HIP LATERAL: ALSO IN THE LATERAL VIEW RECOGNIZABLE INCREASE OF THE RADIOLUCENT LINE PROXIMAL ANTEROLATERAL AND POSTEROMEDIAL. LWS AP-VIEW: PELVIC TILT TO THE LEFT, OSTEOPHYTIC MARGINAL REACTIONS ON THE LEFT. OSTEOCHONDROSIS OF THE FACET JOINTS IN SEGMENT LWK 5 / SWK 1, LEFT STRONGER THAN RIGHT. LWS LATERAL-VIEW: OSTEOCHONDROSIS OF THE FACET JOINTS OF EXPRESSION INCREASINGLY FROM LWK 3/4 ON LWK 4/5 TO LWK 5/S1. INCREAED LORDOSIS IN THE AREA OF THE LUMBOSCRAL TRANSITION (MARKED IN BLACK). SUMMARY: THE RADIOGRAPHIC EVALUATION OF (B)(6) 2016 SHOWED AN INCLINATION ANGLE OF THE CUP OF 45 DEGREES AND A NEUTRAL VERSION WITHOUT CUP MIGRATION, RADIOLUCENCY OR OSTEOLYSIS. NEUTRAL A/P AND LATERAL STEM POSITION, NO STEM SUBSIDENCE, NO RADIOLUCENCY, NO OSTEOLYSIS ON THE X-RAY FROM (B)(6)2016 AN INCLINATION ANGLE OF THE CUP OF APPROXIMATELY 40 DEGREES WITHOUT NOTICEABLE ABNORMALITIES CAN BE MEASURED BY HAND. IN THE RADIOLOGICAL EXAMINATION OF THE RIGHT HIP JOINT 3 MONTHS LATER ON (B)(6)2016 IN AP- AND LATERAL-VIEW AN UNCHANGED CUP POSITION AND A WIDE RADIOLUCENT LINE (APPROXIMATELY ONE X-MILLIMETER) IN THE AREA OF THE PROXIMAL PART OF THE STEM. IT WAS REPORTED ABOUT A 1 YEAR FOLLOW-UP ON (B)(6) 2017. THERE ARE NO CHANGES IN IMPLANT POSITIONING NOTED. THE RADIOGRAPHIC EVALUATION SHOWS IN THE AP-VIEW A 1MM RADIOLUCENCY BETWEEN PROSTHESIS AND BONE INTERFACE. THE X-RAYS OF THE RIGHT HIP JOINT IN AP-VIEW ON (B)(6)2017 SHOWS A NEARLY UNCHANGED POSITION OF THE CUP AND COMPARED TO THE PREVIOUS X-RAY FROM (B)(6)2016 INCREASE OF THE RADIOLUCENT ZONE LATERAL AND MEDIAL. THE SECOND VIEW SHOWS A SLIGHT INCREASE OF THE RADIOLUCENT LINE PROXIMAL. IT WAS REPORTED IN THE 3-YEAR FOLLOW-UP ON (B)(6) 2019 ABOUT A RADIOLOGICALLY 1MM RADIOLUCENCY BETWEEN PROSTHESIS AND BONE INTERFACE. IN THE X-RAY EVALUATION OF THE RIGHT HIP JOINT IN AP-VIEW ON (B)(6)2019 A COMPARATIVELY INCREASING WIDENING OF THE RADIOLUCENCY PROXIMAL IS RECOGNIZABLE. IN THE LATERAL VIEW RECOGNIZABLE INCREASE OF THE RADIOLUCENT LINE PROXIMAL ANTEROLATERAL AND POSTEROMEDIAL. THE RADIOGRAPHIC EVALUATION OF THE LUMBOSACRAL LUMBAR SPINE WITH LUMBOSACRAL JUNCTION RADIOGRAPHIC EXAMINATION OF THE LUMBOSACRAL LUMBAR SPINE SHOWS EVIDENCE ON THE SAME DAY OF THE EXAMINATION SHOWS SIGNS OF DEGENERATIVE CHANGES IN THE FACET JOINTS, MAINLY IN THE AREA OF THE LUMBOSACRAL JUNCTION AND A PELVIC TILT TO THE LEFT. POSITIONING OF THE IMPLANTS: STEM POSITION AND CUP INCLINATION ARE CORRECT, THE ANTEVERSION OF THE CUP CAN NOT BE ASSESSED ON THE BASIS OF THE AVAILABLE IMAGING. A 45 DEGREE CUP INCLINATION IS REPORTED, A CORRESPONDING IMAGING WITH MARKED INCLINATION ANGLE IS NOT AVAILABLE. THE HAND-MEASURED INCLINATION ANGLE IS 5 DEGREES LESS AT ABOUT 40 DEGREES. WITH A CONVENTIONALLY-RADIOLOGICALLY MANUALLY MEASURED INCLINATION ANGLE OF THE CUP, A TOLERANCE LIMIT OF 5 DEGREES CAN BE ASSUMED. OSTEOLYTIC FINDINGS: BASICALLY, THE REPORTED RADIOLUCENCIES IN THE AREA OF THE STEM CAN BE CONFIRMED. ALREADY 3 MONTHS AFTER IMPLANTATION RADIOLOGICAL EVIDENCE FOR RADIOLUCENCY IN THE AREA OF THE PROXIMAL PART OF THE STEM IS RECOGNIZABLE. IN THE FURTHER COURSE UNTIL (B)(6)2019 RADIOLOGICALLY A CLEARLY RECOGNIZABLE INCREASE OF THESE RADIOLUCENCY CAN BE DETERMINED. DEVICE ANALYSIS: NO PRODUCTS WERE RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS AS THEY REMAINED IMPLANTED. 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. DHR: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. CONCLUSION: IT WAS REPORTED THAT THE PATIENT EXPERIENCED FEMORAL RADIOLUCENCY, PAIN AND LEG LENGTH DISCREPANCY STARTING ONE YEAR AFTER IMPLANTATION. THE X-RAY REVIEW CONFIRMED A CORRECT STEM POSITION AND CUP INCLINATION ANGLE. MOREOVER, THE REPORTED RADIOLUCENCY COULD BE CONFIRMED. POSSIBLE ROOT CAUSES FOR THE LEG LENGTH DISCREPANCY, WHICH WAS ONLY NOTED AT THE 3 YEARS FOLLOW UP, COULD BE A SOFT TISSUE LAXITY, OR OSTEOARTHRITIS IN THE JOINTS OF THE LEFT LEG. IN THE SURGEON'S OPINION, A LUMBAR SPINE PROBLEM WOULD BE THE ROOT CAUSE FOR THE PAIN OF THE PATIENT AND THEREFORE THERE IS NO CORRELATION TO THE HIP IMPLANTS. AFTER TREATING THE LUMBAR PROBLEM, THE PATIENT REPORTED A CLEAR DISCOMFORT IMPROVEMENT OF 80%. HOWEVER, BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE FOR THE REPORTED EVENTS 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).
IT WAS NOW REPORTED THAT THE PATIENT WAS IN A CHECK-UP ON (B)(6) 2019 AND (B)(6) 2019. FINDINGS: DISCUS INTERVERTEBRALIS BULGING IN L3/4 AND L4/5 AFFECTING THE NERVE RADICES OSTEOCHONDROSIS WITH SPONDYLOTIC REACTION, OSTEOPHYTES AND ARTHROSIS OF THE INTERVERTEBRAL JOINTS MOSTLY L3 - L5 BUT ALSO L5 ¿ S1 SPINAL CANAL DIAMETER IN L3/4 BORDERLINE IN SAGITTAL AXIS AND NARROWED IN TRANSVERSE AXIS. ADDITIONALLY: INFECTION / INFLAMMATION PARAMETERS WERE NOT HIGH PATIENT COMPLAINS OF PAIN IN THE RIGHT HIP WHEN LOADING WEIGHT, ALSO PARTIALLY ON THE LEFT SIDE. CLIMBING STAIRS IS PARTICULARLY PAINFUL. LYING DOWN ON THE BACK AND ALSO ON THE OPERATED SIDE IS NOT PAINFUL. PAIN COMES FROM THE LUMBAR GLUTEAL AREA TO THE LATERAL SUPERIOR THIGH AND UNTIL THE FOOT. (B)(6) 2019. AFTER ANALYZING ALL CONDITIONS OF DISCOMFORT AND A CONVERSATION WITH THE OPERATING SURGEON, IN PATIENT 148 IS THE TEP RIGHT SIDE NOT CONSIDERED THE CAUSE OF THE PAIN /DISCOMFORT. THE LUMBAR SPINE PROBLEM OF THE PATIENT IS IN DOCTOR¿S OPINION THE ADVERSE EVENT TO BE CONSIDERED.
PLEASE REFER TO REPORT 0009613350 - 2019 - 00334 - 1.
CONCOMITANT MEDICAL PRODUCTS: ITEM# 01.00044.007, LOT# 2848219, ALLOCLASSIC VARIALL, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 48/II ITEM# 00-8775-032-02, LOT# 2834448, BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14. ITEM# 01.00125.020, LOT# 2825940, ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14. ITEM# 00-8774-010-32, LOT# 2830612, ALLOCLASSIC VARIALL BIOLOX DELTA, INSERT, II/32. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY REMAIN IMPLANTED ; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE STUDY REPORT WAS RECEIVED. THE REPORT AS WELL AS DEVICE HISTORY RECORDS (DHR) WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2019-00335. 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). DEVICES REMAIN IMPLANTED.
IT WAS REPORTED THAT RADIOLUCENCY BETWEEN STEM/BONE INTERFACE WAS NOTED DURING THE 1ST YEAR POST IMPLANTATION VISIT. SUBSEQUENTLY, ON 3RD YEAR FOLLOW UP VISIT, IT WAS NOTED THAT THE PATIENT HAS PAIN, 1CM LEG LENGTH DISCREPANCY (LEFT SHORT) AND RADIOLUCENCY AT STEM/BONE INTERFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441029 | BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14 | BIOLOX DELTA CERAMIC FEMORAL HEAD | LZO | ZIMMER GMBH | N/A | 2834448 | 00889024430327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |