(B)(4). LINER AND SHELL WITH PLASTIC BARRIER 36 MM I.D. 48 MM O.D. CONCOMITANT MEDICAL PRODUCTS: ITEM #65771100600 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 6 STANDARD OFFSET LOT# 62746968, ITEM# 00877503602 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14 LOT# 2772607. FOREIGN SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT.
D
Patient 1
IT WAS REPORTED THAT PATIENT EXPERIENCED MODERATE GROIN PAIN MORE THAN 2 YEARS POST IMPLANTATION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE IS AVAILABLE.
N
Patient 1
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: IT WAS IDENTIFIED AN INTERNAL SOFTWARE ERROR PRODUCED AND SUBMITTED AN INVALID DEVICE PRODUCT CODE IN THE PREVIOUS SUBMISSIONS RELATED TO THIS REPORTING. THE DEVICE PRODUCT CODE HAS BEEN UPDATED WITH NO FURTHER CHANGES. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
D
Patient 1
NO FURTHER INFORMATION AVAILABLE
N
Patient 1
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. PATIENT CLINICAL HISTORY NOTES AND MRIS WERE PROVIDED AND THE REVIEW IDENTIFIED THE APPEARANCES ARE NOT CONCERNING FOR INFECTION OR LOOSENING. THERE IS NO PERIPROSTHETIC OSTEOLYSIS. NO CONCERNING FEATURES OF ACTIVE STRESS FRACTURE. NO PERIPROSTHETIC SOFT TISSUE ABNORMALITY DETECTED." NOTED IS A SMALL AMOUNT OF PERIPROSTHETIC BONE MARROW EDEMA IN THE POSTEROSUPERIOR WEIGHT BEARING REGION OF THE ACETABULAR CUP AND LEFT FEMORAL STEM. POSSIBLY A PERIPROSTHETIC MARROW STRESS RESPONSE OR STRESS SHIELDING. RADIOLOGIST QUESTIONS IF PATIENT RECENTLY INCREASED LOW LEVEL ACTIVITY AS THIS COULD BE THE CAUSE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.
D
Patient 1
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.