ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5
Report
- Report Number
- 0002249697-2018-01708
- Event Type
- Injury
- Date Received
- June 5, 2018
- Date of Event
- May 10, 2018
- Report Date
- August 21, 2018
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K121308
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
MODEL #: GTIN. AN EVENT REGARDING DISASSOCIATION, WEAR AND SUBSEQUENT ALTR INVOLVING AN ACCOLADE STEM WAS REPORTED. THE MAR AND CLINICIAN REVIEW CONFIRMED DISASSOCIATION OF THE STEM FROM THE METAL HEAD AND WEAR OF THE TRUNNION. ALTR WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR), DATED 31 MAY 2018 WHICH INDICATED: THE PARTS WERE EXAMINED WITH THE AID OF A STEREO MICROSCOPE AT MAGNIFICATIONS UP TO 50X. THE ANTERIOR, POSTERIOR, SUPERIOR AND INFERIOR SURFACES OF THE STEM CAN BE SEEN. DAMAGES CONSISTENT WITH THE EXPLANTATION PROCESS WERE OBSERVED ON THE STEM IN ADDITION TO BIOLOGICAL FIXATION. ALL SURFACES OF THE NECK EXHIBITED DAMAGE, CONSISTENT WITH WEAR MECHANISMS DUE TO THE HEAD TAPER AND STEM TRUNNION LOSING THEIR TAPER LOCK. DEBRIS WAS ALSO OBSERVED ON THE TRUNNION OF THE STEM. A SAMPLE OF THE DEBRIS WAS PLACED ON A SCANNING ELECTRON MICROSCOPE (SEM). SEM ANALYSIS: ENERGY-DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS WAS PERFORMED ON THE STEM, HEAD, STEM DEBRIS AND HEAD DEBRIS. ELEMENTAL CONSTITUENTS OF THE STEM INCLUDED TI-MO-ZR-FE, WHICH ARE CONSISTENT WITH ASTM F1813 ALLOY. ELEMENTAL CONSTITUENTS OF THE HEAD INCLUDED CO-CR-MO, WHICH ARE CONSISTENT WITH ASTM F1537. ELEMENTAL CONSTITUENTS OF BOTH SAMPLES OF DEBRIS INCLUDED CR-CA-MO-CO-TI-P. THE HIGH PEAKS OF CR AND MO COMPARED TO CO IS CONSISTENT WITH A CORROSION PRODUCT. TI IS CONSISTENT WITH MATERIAL TRANSFER FROM THE HIP STEM. CA AND P IS CONSISTENT WITH BIOLOGICAL MATERIAL. DIMENSIONAL INSPECTION: NOT PERFORMED DUE TO DAMAGE OBSERVED DURING VISUAL INSPECTION. FUNCTIONAL INSPECTION: NOT PERFORMED DUE TO DAMAGE OBSERVED DURING VISUAL INSPECTION. MATERIAL ANALYSIS: A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: DAMAGE WAS OBSERVED ON THE STEM TRUNNION AND HEAD TAPER. THIS DAMAGE WAS CONSISTENT WITH A WEAR MECHANISM DUE TO THE HEAD TAPER AND STEM TRUNNION LOSING THEIR TAPER LOCK. DEBRIS WAS OBSERVED ON THE RETURNED STEM AND HEAD. EDS SHOWED THE STEM WAS CONSISTENT WITH ASTM F1813, THE HEAD WAS CONSISTENT WITH ASTM F1537, AND THE SAMPLES OF DEBRIS WERE CONSISTENT WITH A CORROSION PRODUCT, MATERIAL TRANSFER FROM THE STEM AND BIOLOGICAL MATERIAL. SCRATCHES WERE OBSERVED ON THE INSERT, WHICH IS A COMMON DAMAGE MODE OF UHMWPE. YELLOW DISCOLORATION, CONSISTENT WITH ABSORPTION OF SYNOVIAL FLUID WAS ALSO OBSERVED ON THE INSERT. -MEDICAL RECORDS RECEIVED AND EVALUATION:A REVIEW OF THE PROVIDED PHOTOGRAPHS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: X-RAY PRINTOUTS INCLUDE AN AP AND LATERAL OF THE LEFT HIP, UNDATED, LABELED ¿PRE-REVISION PRIOR TO 05.10/18¿, DEMONSTRATING AN UNCEMENTED LEFT TOTAL HIP ARTHROPLASTY WITH NO SCREWS IN THE ACETABULUM AND THE STEM IN NOMINAL POSITION. THE TRUNNION IS DISASSOCIATED FROM THE HEAD, WHICH REMAINS IN THE ACETABULUM. ONE UNLABELED INTRAOPERATIVE COLOR PHOTOGRAPH OF A SURGICAL INCISION DEMONSTRATES A METALLIC FEMORAL HEAD VISIBLE AT THE DEPTH OF THE INCISION WITH COPIOUS AMOUNTS OF BLACK DEBRIS IN SITU. SIXTEEN PHOTOGRAPHS OF AN EXPLANTED HEAD, STEM AND POLY LINER SHOW EVIDENCE OF MEDIAL NOTCHING AND SUPEROLATERAL WEAR OF THE TRUNNION. BASED UPON THE INFORMATION AVAILABLE FOR REVIEW, NO DETERMINATION CAN BE MADE FOR THE CAUSE OF THE APPARENT LOSS OF THE MECHANISM OF THE HEAD/TRUNNION JUNCTION, WHICH APPEARS TO HAVE RESULTED IN THE CASCADE OF EVENTS DESCRIBED IN THIS CLINICAL SITUATION. -DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: BASED UPON THE INFORMATION AVAILABLE FOR REVIEW, ROOT CAUSE COULD NOT BE DETERMINED. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
AS REPORTED: "PATIENT BENT OVER APPROXIMATELY (B)(6) 2018, IMPLANT GAVE WAY. PATIENT FELL AND SUSTAINED MINOR INJURIES TO FACE AND HANDS". INTRA-OP PHOTO SHOWS BLACK MATERIAL INSIDE THE PATIENT. EXPLANT PHOTO SHOWS BLACK DEBRIS ON THE TRUNNION. UPON RECEIPT AND INSPECTION OF THE DEVICE, NO EVIDENCE OF ANY FRACTURE IS FOUND. HOWEVER, THE TRUNNION HAS NOTICEABLE WEAR ON IT. UPDATE: A REVIEW BY A CLINICAL CONSULTANT CONFIRMED DISASSOCIATION OF THE STEM AND METAL HEAD.
REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAS BEEN ONE OTHER EVENTS FOR THE LOT REFERENCED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
AS REPORTED: "PATIENT BENT OVER APPROXIMATELY (B)(6) 2018, IMPLANT GAVE WAY. PATIENT FELL AND SUSTAINED MINOR INJURIES TO FACE AND HANDS". INTRA-OP PHOTO SHOWS BLACK MATERIAL INSIDE THE PATIENT. EXPLANT PHOTO SHOWS BLACK DEBRIS ON THE TRUNNION. UPON RECEIPT AND INSPECTION OF THE DEVICE, NO EVIDENCE OF ANY FRACTURE IS FOUND. HOWEVER, THE TRUNNION HAS NOTICEABLE WEAR ON IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 413670 | ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5 | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | LPH | STRYKER ORTHOPAEDICS-MAHWAH | 18802902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |