METASUL HD 28MM L 12/14
Report
- Report Number
- 0009613350-2018-00586
- Event Type
- Injury
- Date Received
- June 5, 2018
- Date of Event
- February 2, 2016
- Report Date
- September 4, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
DHR-REVIEW: REF#: (B)(4). LOT#: 2179968 - YIELD: 40 - DELIVERED: 40 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF#: (B)(4). LOT#: 2179277 - YIELD: 60 - DELIVERED: 60 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF#: (B)(4). LOT#: 2181596 - YIELD: 10 - DELIVERED: 10 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF#: (B)(4). LOT#: 2116632 - YIELD: 25 - DELIVERED: 25 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: REVISION DUE TO WEAR, REVISION DUE TO INLAY DISLOCATION EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A METASUL INLAY IN THE RIGHT HIP ON (B)(6) 2003 AND REQUIRED REVISION SURGERY OF THE INLAY AND THE HEAD ON (B)(6)2016 DUE TO WEAR OF THE INLAY. REVIEW OF RECEIVED DATA: - 2 X-RAYS HAVE BEEN RECEIVED. THE EVALUATION HAS BEEN PERFORMED BY A HCP. - X-RAY DATED (B)(6)2015 PELVIS VIEW AP: CUP INCLINATION ANGLE RIGHT APPROX. 52°, LEFT APPROX. 44°. LEFT: CONCERNING LEFT HIP. RADIOLOGICAL NO VISIBLE RIM AREA AROUND THE IMPLANT ON THE LEFT SIDE. AT THE LATERAL CUP CLOSE TO THE IMPLANT SMALL OSSEOUS RESORPTION-ZONE. INLAY TILTED WITHIN CUP, FEMUR HEAD DECENTRALIZED TO CRANIAL, SMALL GROOVE VISIBLE AT THE MEDIAL CONUS. RIGHT: NARROW RIM AREA ON THE RIGHT SIDE AT THE TRANSITION CUP/ACETABULUM WITHIN THE AREA OF THE CRANIAL CUP. NARROW RIM AREA AT THE LATERAL STEM SHOULDER. FEMUR HEAD DECENTRALIZED TO CRANIAL, DISLOCATION OF THE INLAY NOT CLEARLY VISIBLE. THE INCLINATION ANGLE OF 52° OF THE CUP WAS FOUND TO BE RATHER STEEP. - X-RAY UNDATED PELVIS VIEW AP: CONDITION AFTER IMPLANTATION OF A REVISION STEM LEFT WITHOUT INDICATION FOR LOOSENING OR IMPLANT MALFUNCTIONING, INTACT METAPHYSEAL CERCLAGE ABOVE AND BELOW THE MINOR TROCHANTER. - PATIENT HISTORY INCLUDING TWO SURGICAL REPORTS FROM AUGUST 18, 2015 (REVISION LEFT) AND (B)(6)2016 (REVISION RIGHT) WITH THE CORRESPONDING DISCHARGE DOCUMENTATION: - SURGICAL REPORT (B)(6)2015, CONCERNING LEFT HIP. - DISCHARGE DOCUMENTATION (B)(6) 2015, CONCERNING LEFT HIP. - SURGICAL REPORT (B)(6) 2016: INDICATION: SINCE A FEW WEEKS RELAPSING SNAPPING OF THE RIGHT HIP, FROM A RADIOLOGICAL PERSPECTIVE A WELL SEATED CEMENTLESS ACA-CUP AND A CEMENTLESS OPTAN-STEM WITH STARTING DISLOCATION OF THE METASUL-INLAY WITHIN THE PE-BODY. DIAGNOSIS: WEARING OF THE INLAY WITH STARTING DISLOCATION OF THE METASUL-INLAY RIGHT CONDITION AFTER CEMENTLESS HIP TEP RIGHT WITH METASUL ARTICULATION IMPLANTED IN 2003 CONDITION AFTER REVISION OF INLAY AND STEM OF THE LEFT HIP PERFORMED AUGUST 2015. THERAPIE: REVISION OF HEAD AND INLAY RIGHT. SURGERY: OPENING OF PREVIOUS ACCESS. NO MACROSCOPIC INDICATION FOR METALLOSIS OR PRESENCE OF A PSEUDOTUMOR. CUP AND PROXIMAL STEM ARE WELL, FIRMLY SEATED AND WILL BE LEFT AS FOUND. VISIBLE TILTING OF THE METASUL-INLAY WITHIN PE-BODY. CRANIAL CLEARLY VISIBLE AGEING DEFECTS OF THE PE WHICH EXPLAIN THE STARTING INLAY DISLOCATION. NO IMPINGEMENT OR ARROSION OF THE PROSTHESIS-NECK. FIRMLY SEATED CUP WITH CORRECT ALIGNMENT WITHOUT MACROSCOPIC VISIBLE CHANGES. REMOVAL OF THE PE-METASUL-INLAY AND INSERTION OF A NEW DURASUL ALPHA INLAY 28 MM HOODED WITH STABLE POSITION. MOUNTING OF A 28 MM OPTION DELTA CERAMIC HEAD XL. CLOSURE. - DISCHARGE DOCUMENTATION (B)(6) 2016: ANAMNESIS: PATIENT EXPERIENCED RELAPSING SNAPPING OF HER RIGHT HIP SINCE A FEW WEEKS. FROM A RADIOLOGICAL PERSPECTIVE A WELL SEATED IMPLANT POSITION WITH STARTING DISLOCATION OF THE METASUL-INLAY WITHIN THE PE-BODY. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION OF USING RMW (ALPHA INSERT): - 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. - METAL DEBRIS, BREAKAGE OF INSERT, STEM NECK FRACTURE, DISLOCATION OR LUXATION, OSTEOLYSIS / METALLOSIS DUE TO INAPPROPRIATE INSERT DESIGN CONCERNING RANGE OF MOTION (E.G. HOODED INSERTS) LEADING TO IMPINGEMENT OF COMPONENTS . => NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. - DEFORMATION OF INSERT (DUE TO LOAD) DUE TO OVALISATION OF COMPATIBLE SHELL COMPONENT. => NOT POSSIBLE, AS DURING REVISION SURGERY THE SHELL WAS FOUND TO BE STABLE, CORRECTLY POSITIONED AND WITHOUT ANY MACROSCOPIC NON-CONFORMANCE AND THEREFORE LEFT IN-SITU. - REDUCED PERFORMANCE OF MATERIAL DUE TO AGING OF SULENE PE DUE TO STERILIZATION METHOD AT SUPPLIER. => NOT POSSIBLE, AS THE DHR/STERILIZATION CERTIFICATE DID NOT SHOW ANY NON-CONFORMANCE OF THE PRODUCT SPECIFICATION. - MIGRATION, DETACHMENT OF CERAMIC OR METAL PART IN POLYETHYLENE (SANDWICH CONSTRUCTION) DUE TO CREEPING OF POLYETHYLENE, LOSS OF FUNCTION. => POSSIBLE, AS DURING REVISION SURGERY THE INLAY SHOWED AGEING DEFECTS CONSISTING OF A ROUGHENED SURFACE AND FRACTURE LINES. - IMPLANT DISLOCATION / LOOSENING / FRACTURE DUE TO SELECTION OF WRONG COMPONENTS. => NOT POSSIBLE, AS THE COMPATIBILITY CHECK SHOWED THAT THE IMPLANTED COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE DETERMINATION OF THE USING RMW (METASUL 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, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, ABRASIVE WEAR DUE TO INSUFFICIENT CONNECTION STRENGTH BETWEEN STEM AND HEAD DUE TO INSUFFICIENT MATERIAL PROPERTIES AND/OR DESIGN. => NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN/MATERIAL WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION. - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, POSTOPERATIVE TISSUE REACTION, METALOSIS, DISLOCATION, ASEPTIC LOOSENING OF STEM DUE TO EXCESSIVE WEAR DUE TO MICROMOTION IN TAPER CONNECTION BETWEEN STEM AND HEAD (E.G FRETTING). => NOT POSSIBLE, AS THE TAPER OF THE IMPLANTED STEM WAS FOUND TO BE FINE, THEREFORE, THE STEM WAS LEFT IN-SITU. - POSTOPERATIVE TISSUE REACTION, METALOSIS, DISLOCATION, ASEPTIC LOOSENING OF STEM DUE TO PE OR METAL PARTICLE RELEASE FROM ARTICULATION OR TAPER CONNECTION. => POSSIBLE, AS THE INSERT ARTICULATION SURFACE WAS FOUND TO BE ROUGHENED AND TO HAVE FRACTURE LINES, SOME AMOUNT OF PE OR METAL RELEASE CAN BE ASSUMED. - DISLOCATION, SUBLUXATION, ABRASIVE WEAR, LOOSENING OF COMPONENTS DUE TO TISSUE IMPINGEMENT PRIOR TO PROPER TAPER FIT. => POSSIBLE, AS WE DO NOT HAVE ANY SURGICAL REPORT DOCUMENTING THE PRIMARY SURGERY THIS CAUSE CANNOT BE EXCLUDED. - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, DISLOCATION, SUBLUXATION, ABRASIVE WEAR DUE TO IMPINGEMENT DUE TO MALPOSITION OF COMPONENTS (STEM, HEAD, CUP). => POSSIBLE, AS WE DO NOT HAVE ANY SURGICAL REPORT DOCUMENTING THE PRIMARY SURGERY THIS CAUSE CANNOT BE EXCLUDED. - DISLOCATION, SUBLUXATION, LEG LENGTH DIFFERENCE, ASEPTIC LOOSENING OF COMPONENTS DUE TO SELECTION OF WRONG COMPONENTS (E.G. WRONG SIZE OF HEAD DIAMETER AND/OR OFFSET). => NOT POSSIBLE, AS THE COMPATIBILITY CHECK SHOWED THAT THE USED IMPLANT COMBINATION WAS APPROVED BY ZIMMER BIOMET. FURTHER, REVIEW OF THE X-RAY IMAGES DID NOT FOUND ANY EVIDENCE OF WRONG IMPLANTES SIZES. - DISLOCATION, SUBLUXATION, ABRASIVE WEAR DUE TO SCRATCHES ON ARTICULAR SURFACE DURING SURGERY. => POSSIBLE, AS WE DO NOT HAVE ANY SURGICAL REPORT DOCUMENTING THE PRIMARY SURGERY THIS CAUSE CANNOT BE EXCLUDED. - 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). => NOT POSSIBLE, AS THE STEM TAPER WAS FOUND TO BE FINE DURING REVISION SURGERY AND THEREFORE LEFT IN-SITU. - DAMAGED IMPLANT, DISLOCATION, SUBLUXATION, ABRASIVE WEAR, LOOSENING OF COMPONENTS DUE TO EXPLANTED METASUL HEAD (WITH E.G. A DAMAGED TAPER AND/ OR SCRATCHES ON THE SURFACE) IS REUSED FOR NEW IMPLANTATION SURGERY. => POSSIBLE, AS WE DO NOT HAVE ANY SURGICAL REPORT DOCUMENTING THE PRIMARY SURGERY THIS CAUSE CANNOT BE EXCLUDED. - DISLOCATION, SUBLUXATION, ABRASIVE WEAR, LEG LENGTH DISCREPANCY DUE TO SOFT TISSUE LAXITY. => POSSIBLE, AS SOFT TISSUE LAXITY COULD SLIGHTLY CHANGE THE POSITIONING OF THE PARTS. - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, ABRASIVE WEAR, DISLOCATION, SUBLUXATION, FRACTURE OF STEM, LEG LENGTH DISCREPANCY DUE TO OFF LABEL USE; WRONG COMBINATION OF COMPONENTS USED; COMBINATION WITH COMPETITOR PRODUCTS. => NOT POSSIBLE, AS THE COMPATIBILITY CHECK SHOWED THAT THE USED IMPLANT COMBINATION WAS APPROVED BY ZIMMER BIOMET. FURTHER, NO OFF-LABEL USE WAS IDENTIFED DURING INVESTIGATION. CONCLUSION SUMMARY: BASED ON THE GIVEN INFORMATION THE COMPLAINT COULD BE CONFIRMED. ACCORDING TO THE SURGICAL REPORT OF THE REVISION SURGERY PERFORMED ON (B)(6)2016, THE PATIENT HAD EXPERIENCED A RELAPSING SNAPPING OF HER RIGHT HIP FOR A FEW WEEKS. THE CONSULTATION (INCLUDING X-RAY) SHOWED WEARING OF THE INLAY AND STARTING METASUL-INLAY DISLOCATION WITHIN THE PE-BODY OF THE RIGHT HIP, CONDITION FOLLOWING CEMENTLESS RIGHT HIP TEP WITH METASUL ARTICULATION IMPLANTED IN 2003. DUE TO THIS A REVISION OF THE INLAY AND THE HEAD WAS PERFORMED ON FEBRUARY 02, 2016. AS THE ACA-CUP AS WELL AS THE OPTAN STEM STILL HAD A FIRM AND WELL ALIGNED SEAT THEY WERE LEFT IN-SITU. DURING SURGERY THE METASUL-INLAY WAS FOUND TO BE SLIGHTLY TILTED WITHIN THE PE-BODY. THE PE-BODY SHOWED, ESPECIALLY CRANIAL, DISTINCTIVE AGEING DEFECTS CONSISTING OF A ROUGHENED SURFACE AND RADIAL FRACTURE LINES, WHICH INDUCED THE STARTING INLAY DISLOCATION. THE SURGERY WAS PERFORMED WITHOUT COMPLICATIONS. ACCORDING TO THE DISCHARGE DOCUMENTATION THE PERI- AND POST OPERATIVE COURSE DID NOT SHOW ANY COMPLICATIONS. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. MOREOVER, THE STEEP INCLINATION ANGLE OF 52° OF THE CUP COULD BE A RISK FACTOR FOR THE REPORTED EVENT (AGEING OF THE INLAY, METASUL DISLOCATION). THEREFORE, BASED ON THE GIVEN INFORMATION AND THE MISSING PRODUCTS, WE WERE NOT ABLE TO DETERMINE A SPECIFIC ROOT CAUSE FOR THE REPORTED ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00585 -2. .
ADDITIONAL INFORMATION WAS RECEIVED: A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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).
THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00585. CONCOMITANT MEDICAL PRODUCTS: METASUL, ALPHA INSERT, GG/28, REF# 01.00010.407, LOT# 2179968. ACA ANCHORAGE CAP 50/GG, REF# 409.0141, LOT# 2181596. OPTAN, STEM, RIGHT, UNCEMENTED, 11, TAPER 12/14, REF# 01.00063.011, LOT# 2116632. THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E REF# 00-8770-032-02, METASUL KOPF 32, 12/14, GRÖSSE M/0, (B)(4)) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES FOR REVIEW. X-RAY PICTURES AND SURGICAL REPORTS WERE 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. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).
IT WAS REPORTED THAT A PATIENT WAS IMPLANTED A THA ON THE RIGHT HIP AND REQUIRED REVISION SURGERY OF THE INLAY AND HEAD AFTER MORE THAN 12 YEARS IN VIVO DUE TO WEAR OF THE INLAY. THIS IS A BILATERAL PATIENT, THE LEFT HIP IS REPORTED IN CASE (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414399 | METASUL HD 28MM L 12/14 | METASUL HEAD | KWA | ZIMMER GMBH | N/A | 2179277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |