UNKNOWN ALLOCLASSIC ZWEYMULLER CFS STEM HIP
Report
- Report Number
- 0009613350-2019-00062
- Event Type
- Injury
- Date Received
- February 12, 2019
- Date of Event
- November 10, 2018
- Report Date
- September 5, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION RESULTS WERE MADE AVAILABLE. CONCOMITANT MEDICAL PRODUCTS ACCORDING D11: - METASUL ALPHA INSERT, JJ/28, REF#: (B)(4). LOT#: 2043654 - ECHO B-MTRC MP RP SO 7, REF#: (B)(4). , LOT#: 2055484 - FITEK SHELL HIP, REF#: UNKNOWN, LOT#: UNKNOWN. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. THE MISSING INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. DHR REVIEW: AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. TREND ANALYSIS: ANALYSIS COULD NOT BE PERFORMED AS NO ITEM NUMBER IS AVAILABLE. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERIPROSTHETIC PROXIMAL FEMUR FRACTURE TYPE UCS B1 ON (B)(6) 2018. EXCESSIVE CUP INCLINATION ANGLE STATUS AFTER IMPLANTATION OF A CEMENTLESS HIP TEP IN 2001 (TRANSGLUTEAL WITH MOM-ARTICULATION) AND STATUS AFTER UNDISPLACED PERIPROSTHETIC ACETABULAR FRACTURE OF POSTERIOR PILLAR TYPE UCS B1 (B)(6) 2016). REVIEW OF RECEIVED DATA: - IN TOTAL 42 X-RAY AND CT IMAGES HAVE BEEN RECEIVED. THE IMAGES TAKEN ON (B)(6) 2017, (B)(6) 2017, (B)(6) 2018, (B)(6) 2018 AND (B)(6) 2018 WERE INCLUDED IN THE ANALYSIS OF THIS CASE. THE FOLLOWING X-RAY EVALUATION WAS PERFORMED BY A HEALTH CARE PROFECSSIONAL (HCP). -(B)(6) 2017 PELVIS OVERVIEW AND LAUENSTEIN VIEW. A FRACTURE OF THE TROCHANTER MINOR, SLIGHTLY DISLOCATED, CAN BE OBSERVED ON THE MEDIAL SIDE OF THE LEFT HIP STEM. A CLEARLY VISIBLE DISCONTINUITY OF THE CORTICAL BONE IS SEEN ON THE POSTEROLATERAL SIDE OF THE PROXIMAL FEMUR. - (B)(6) 2017 LAUENSTEIN VIEW. THERE IS A FRACTURE LINE VISIBLE IN THE PROXIMAL PART OF THE FEMUR ON THE POSTEROLATERAL SIDE OF THE STEM. (B)(6) 2018 PELVIS OVERVIEW AND LAUENSTEIN VIEW. BEGINNING CALLUS FORMATION CAN BE OBSERVED IN THE REGION OF THE TROCHANTER MINOR FRACTURE. A SMALL RADIOLUCENT LINE IS SEEN ON THE LATERAL STEM SHOULDER. COMPARED WITH THE PREVIOUS LAUENSTEIN VIEW THE ORIENTATION OF THE FEMUR AS WELL AS THE BRIGHTNESS/CONTRAST ARE DIFFERENT. IN THIS VIEW THE FRACTURE OF THE TROCHANTER MINOR IS NO MORE VISIBLE. (B)(6) 2018 PELVIS OVERVIEW AND LAUENSTEIN VIEW. THERE IS CALLUS FORMATION AT THE TROCHANTER MINOR FRACTURE. THE RADIOLUCENT LINE ON THE LATERAL STEM SHOULDER SEEMS TO BE SLIGHTLY INCREASED. BASED ON THE ORIENTATION OF THE FEMUR THIS VIEW IS COMPARABLE WITH THE LAUENSTEIN VIEW TAKEN ON (B)(6) 2017. IN THIS VIEW A RADIOLUCENT GAP IS SEEN ALONG THE POSTEROMEDIAL SIDE OF THE PROXIMAL HALF OF THE STEM. THE TROCHANTER MINOR FRACTURE LINE IS STILL VISIBLE AND SLIGHT CALLUS FORMATION CAN BE SEEN. (B)(6) 2018 PELVIS OVERVIEW AND LAUENSTEIN VIEW. THE TROCHANTER MINOR FRACTURE SEEMS TO BE HEALED. THE GAP ON THE POSTEROMEDIAL SIDE OF THE PROXIMAL HALF OF THE STEM IS NOW BORDERED BY A SCLEROTIC LINE ON THE BONE SIDE. THE TROCHANTER MINOR FRACTURE LINE IS NO MORE VISIBLE. - REPORT OF REVISION SURGERY PERFORMED ON(B)(6) 2018 DIAGNOSIS: SYMPTOMATIC REACTION TO METAL WEAR AND OSTEOLYSIS OF THE LEFT HIP ACETABULUM, WITH: - EXCESSIVE CUP INCLINATION AFTER IMPLANTATION OF AN UNCEMENTED THP IN 2001 (TRANSGLUTEAL WITH METAL-ON-METAL PAIRING) - STATE AFTER NON-DISPLACED PERIPROSTHETIC ACETABULAR FRACTURE OF THE POSTERIOR COLUMN, TYPE UCS B1 ON (B)(6) 2016 - STATE AFTER PERIPROSTHETIC PROXIMAL FEMUR FRACTURE TYPE UCS B1 ON (B)(6) 2018 INDICATION: SEE DIAGNOSIS. DUE TO A MALPOSITIONING OF THE CUP, WITH AN INCLINATION OF 63°, THE OPTION TO ONLY CHANGE THE INSERT IS DISCARDED. IN ADDITION, THERE IS QUESTIONABLE SYMPTOMATIC OSTEOLYSIS OF THE ACETABULUM. PROCEDURE: IN-SITU REMOVAL OF THE HEAD. THE TAPER SHOWS CORROSION, HOWEVER, THE ORIGINAL MANUFACTURING SURFACE STRUCTURE IS STILL VISIBLE AND THERE IS NO LOSS OF SUBSTANCE. THE STEM IS FIRMLY FIX. REPOSITION WITH A L-TRIAL HEAD. NO INSTABILITY NOTED UNDER EXTENTION AND OUTER ROTATION. FOR CORRECTION OF THE LEG LENGTH A BIOLOX OPTION HEAD 36/XL IS MOUNTED. DEVICES ANALYSIS: DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2018 THE FITMORE SHELL, THE METASUL HEAD AND THE METASUL LINER WERE REMOVED. REFER TO (B)(4) FOR THE VISUAL EXAMINATION OF THESE THREE PRODUCTS. AS THE ALLOCLASSIC ZWEYMÜLLER STEM WAS FOUND TO BE WELL SEATED DURING THE REVISION SURGERY, THE STEM WAS LEFT IN-SITU. THEREFORE, THE STEM REMAINS 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. CONCLUSION SUMMARY: BASED ON THE SURGICAL REPORT OF THE REVISION SURGERY PERFORMED ON (B)(6) 2018 THE PATIENT EXPERIENCED A PERIPROSTHETIC PROXIMAL FEMUR FRACTURE TYPE UCS B1 ON (B)(6) 2018. BASED ON THE PROVIDED X-RAY AND CT IMAGES A FRACTURE OF THE TROCHANTER MINOR CAN BE CONFIRMED, HOWEVER, ACCORDING TO THE IMAGES THE FRACTURE OCCURRED ON (B)(6) 2017 RATHER THAN ON (B)(6) 2018 AS REPORTED. THE REVISION REPORT OF THE SURGERY PERFORMED ON (B)(6) 2018 STATES A MALPOSITIONING OF THE CUP, WITH AN INCLINATION ANGLE OF 63°. THE TAPER SHOWED SOME CORROSION, BUT WAS OTHERWISE FINE TO BE LEFT IN-SITU. THE STEM WAS FIRMLY FIX, THEREFORE, THE STEM REMAINED IMPLANTED AND A NEW CERAMIC HEAD WITH A TRUNNION SLEEVE WAS MOUNTED. THE QUALITY RECORDS COULD NOT BE REVIEWED AS THE DEVICE IDENTIFICATION OF THE STEM IS UNKNOWN. THERE IS NO INFORMATION AT HAND ON THE CIRCUMSTANCES THAT LED TO THE PERIPROSTHETIC FEMUR FRACTURE E.G. PATIENT FALL OR COMORBITIES, ESPECIALLY, AS THE STEM WAS FOUND TO HAVE A FIRM SEAT. THEREFORE, A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED EVENT. 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). NOTE: TWO OTHER CASES WERE OPENED FOR THE SAME PATIENT : ZIMMER BIOMET REFERENCE NUMBERS (B)(4). (REVISION DUE TO ELEVATED METAL ION LEVELS) AND (B)(4). (ACETABULAR FRACTURE).
INVESTIGATION RESULTS ARE NOW AVAILABLE.
THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW AS THE STEM HAS NOT BEEN REVISED. X-RAY PICTURES AND MEDICAL DOCUMENTS WAS RECEIVED AND WILL BE REVIEWED WITHIN THE INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, 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 ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERIPROSTHETIC PROXIMAL FEMUR FRACTURE TYPE UCS B1 AFTER 17 YEARS IN VIVO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123692 | UNKNOWN ALLOCLASSIC ZWEYMULLER CFS STEM HIP | ALLOCLASSIC ZWEYMUELLER FEMORAL STEM | LZO | ZIMMER GMBH | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |