UNK STEM

Description of Event or Problem

A JOURNAL ARTICLE WAS OBTAINED ON 18-JUN-2026 THAT REPORTED A RETROSPECTIVE, SINGLE INSTITUTION STUDY FROM CANADA. THE PURPOSE OF THE STUDY WAS TO EXAMINE THE OUTCOMES OF VANCOUVER B2 AND B3 FRACTURES TREATED WITH A SINGLE MODULAR TAPERED FLUTED STEM HIP SYSTEM, THE ZIMMER MODULAR REVISION (ZMR), WITH A MINIMUM 1-YEAR FOLLOW-UP. THE STUDY REVIEWED FORTY-FOUR PATIENTS BETWEEN 2006 AND 2020, WITH 36 VANCOUVER B2 FRACTURES AND 8 VANCOUVER B3 FRACTURES. IN ALL CASES, A ZMR STEM WAS USED (34 XL TAPER/ 10 REVISION TAPER); (15 CEMENTED/ 29 UNCEMENTED); EIGHT PATIENTS WERE REVISED TO A ZIMMER TM CUP, THREE PATIENTS USED A CONSTRAINED LINER, FOUR PATIENTS REQUIRED A CORTICAL ALLOGRAFT, ALL USING AN ANTEROLATERAL APPROACH OR A MODIFIED EXTENDED TROCHANTERIC OSTEOTOMY (ETO). A MODIFIED ETO WAS USED FOR ALL REVISIONS OF CEMENTED IMPLANTS AND FOR REVISIONS OF CEMENTLESS IMPLANTS WHEN THE FRACTURE PATTERN WAS SUCH THAT CONVERSION TO AN ETO WAS STRAIGHTFORWARD. IF THE ACETABULAR COMPONENT WAS POORLY POSITIONED, BUT WELL FIXED, A LINER WAS CEMENTED IN A MORE ACCEPTABLE POSITION. PROXIMAL FRACTURE FRAGMENTS WERE REDUCED WITH CERCLAGE WIRES AND IN SELECT CASES, A CORTICAL STRUT ALLOGRAFT WAS USED TO AUGMENT BONE STOCK AND CONSTRUCT STABILITY. THE STUDY POPULATION HAD A MEAN AGE OF 71.6 ± 12.5 YEARS AT TIME OF SURGERY (RANGE,33-93 YEARS); (20 MALES/24 FEMALES); (MEAN BMI 28.6 ± 7.0, RANGE 20-52). FOLLOW-UP WAS CONDUCTED AT SIX WEEKS, THREE MONTHS, ONE YEAR, AND EVERY YEAR THEREAFTER, WITH A MEAN LENGTH OF FOLLOW-UP FOR 50.2 MONTHS (RANGE, 12-168 MONTHS). JEREMY KUBIK MARGARET S. JURYN SAHIL KOONER OLEG SAFIR, ALLAN GROSS AND PAUL KUZYKCAN J SURG MARCH 17, 2026 69 (2) E122-E129. THE LITERATURE REPORTED THREE PATIENTS WITH A VANCOUVER TYPE C FRACTURE, REQUIRED AN ORIF FOR REPEAT PERIPROSTHETIC FRACTURES THAT OCCURRED WITHIN A MEAN OF 38 MONTHS POST-OPERATIVE. ALL FRACTURES HEALED WITHOUT REPORTED COMPLICATIONS. PLEASE REFERENCE JOURNAL ARTICLE: HTTPS://DOI.ORG/10.1503/CJS.011125. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. G2: FOREIGN - EVENT OCCURRED IN CANADA. G2: LITERATURE - CAN J SURG MARCH 17, 2026 69 (2) E122-E129. DOI: HTTPS://DOI.ORG/10.1503/CJS.011125 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.