UNKNOWN STEM

Additional Manufacturer Narrative

(B)(4). B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. D10: UNKNOWN DM BEARING, UNKNOWN G7 SHELL, UNKNOWN LINER, UNKNOWN HEAD. G2: GENG, Z.; ASAMU, A.-S.; ALDRIDGE, W.; NG, A.B.Y. FUNCTIONAL AND SAFETY OUTCOMES OF THIRD-GENERATION ZIMMER BIOMET G7® DUAL MOBILITY TOTAL HIP ARTHROPLASTY IN FEMORAL NECK FRACTURES: A RETROSPECTIVE COHORT STUDY. J. CLIN. MED. 2025, 14, 8350. HTTPS://DOI.ORG/ 10.3390/JCM14238350. G2: FOREIGN ¿ UNITED KINGDOM. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) ¿ STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 TRENDS.

Description of Event or Problem

A JOURNAL ARTICLE WAS OBTAINED ON 06-JAN-2026 THAT REPORTED A RETROSPECTIVE COHORT STUDY FROM THE UNITED KINGDOM. THE PURPOSE OF THE STUDY WAS TO ASSESS THE PATIENTS¿ FUNCTIONAL RECOVERY, SAFETY (COMPLICATION PROFILE), AND IMPLANT RADIOGRAPHIC OUTCOMES IN TRAUMATIC FEMORAL NECK FRACTURE PATIENTS TREATED WITH A DUAL MOBILITY PRIMARY TOTAL HIP ARTHROPLASTY. THE STUDY WAS CONDUCTED AT MID-YORKSHIRE TEACHING HOSPITALS NHS TRUST BETWEEN JANUARY 2021 AND DECEMBER 2023. THE STUDY REVIEWED 120 HIPS. ALL PATIENTS RECEIVED A PRESS-FIT (UNCEMENTED) ZIMMER BIOMET G7 ACETABULAR SHELL WITH A DUAL MOBILITY HEAD AND LINER. AN ACETABULAR SCREW WAS IMPLANTED AT THE PREFERENCE OF THE OPERATING SURGEON. FEMORAL STEMS CONSISTED OF AN UNCEMENTED DEPUY CORAIL (24 HIPS) OR A CEMENTED STEM, ZIMMER BIOMET CPT (91 HIPS) OR DEPUY SYNTHES C-STEM (2 HIPS). THREE STEMS WERE UNKNOWN, AND CEMENT MANUFACTURER WAS NOT SPECIFIED. THE STUDY POPULATION HAD A MEAN AGE OF 71.6 YEARS AT TIME OF SURGERY; (89 FEMALES / 31 MALES). FOLLOW-UP CONSISTED OF RETROSPECTIVE REVIEW OF ONE-YEAR POSTOP RADIOGRAPHS AND OXFORD HIP SCORES. GENG, Z.; ASAMU, A.-S.; ALDRIDGE, W.; NG, A.B.Y. FUNCTIONAL AND SAFETY OUTCOMES OF THIRD-GENERATION ZIMMER BIOMET G7® DUAL MOBILITY TOTAL HIP ARTHROPLASTY IN FEMORAL NECK FRACTURES: A RETROSPECTIVE COHORT STUDY. J. CLIN. MED. 2025, 14, 8350. HTTPS://DOI.ORG/ 10.3390/JCM14238350. COMPLAINT 15: THE ARTICLE REPORTED 5 PATIENTS IN THE CEMENTED GROUP EXPERIENCED CHRONIC HIP PAIN >6 WEEKS POSTOP. NO FURTHER INFORMATION WAS PROVIDED REGARDING TREATMENT OR OUTCOMES. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.