UNK HEAD

Additional Manufacturer Narrative

(B)(4) PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. D10: UNK WAGNER STEM. G2: GONZÁLEZ-ADRIO, R.L., PACHA, D., ALIAGA-MARTÍNEZ, A. ET AL. TOTAL HIP ARTHROPLASTY AS RECONSTRUCTIVE TREATMENT IN PATIENTS WITH CEREBRAL PALSY: A COMPARATIVE STUDY OF POSTOPERATIVE OUTCOMES BETWEEN PATIENTS WITH DEVELOPMENTAL HIP DYSPLASIA AND CEREBRAL PALSY HIP DYSPLASIA. EUR J ORTHOP SURG TRAUMATOL 36, 155 (2026). HTTPS://DOI.ORG/10.1007/S00590-026-04701-5. G2: FOREIGN: SPAIN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

A JOURNAL ARTICLE WAS OBTAINED ON 22-JUN-2026 THAT REPORTED A RETROSPECTIVE STUDY FROM SPAIN. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE ROLE OF TOTAL HIP ARTHROPLASTY (THA) IN FUNCTIONAL OUTCOMES, PAIN RELIEF, RESTORING FUNCTION, AND IMPROVED QUALITY OF LIFE IN INDIVIDUALS WITH CEREBRAL PALSY HIP DYSPLASIA (CPHP) THROUGH COMPARISON WITH PATIENTS WITH DEVELOPMENTAL HIP DYSPLASIA (DDH). THE STUDY REVIEWED 72 PATIENTS (14 CPHP/ 58 DDH) UNDERGOING PRIMARY THA BETWEEN 10-NOV-2016 AND 31-DEC-2022 AT A TERTIARY TRAUMA CENTER. ALL PROCEDURES USED POSTEROLATERAL APPROACH WITH A CEMENTLESS WAGNER SL STEM AND A ZIMMER BIOMET ACETABULAR COMPONENT (G7, TRILOGY, OR TMT). IN THE STUDY AN ILIOPSOAS TENOTOMY WAS PERFORMED IN 100% OF PATIENTS WITH CP AND IN 3.4% OF PATIENTS WITH DEVELOPMENTAL DYSPLASIA OF THE HIP (DDH). IN NON-AMBULATORY PATIENTS WITH CP, AN ADDITIONAL HIP FLEXOR TENOTOMY IS PERFORMED THROUGH AN ACCESSORY APPROACH AT THE LEVEL OF THE ANTERIOR SUPERIOR ILIAC SPINE (ASIS), BASED ON THE PREOPERATIVE CLINICAL EXAMINATION. IN AMBULATORY PATIENTS, THE INDICATION FOR THIS TENOTOMY IS ASSESSED INTRAOPERATIVELY AFTER TRIAL COMPONENT INSERTION. HIP FLEXOR TENOTOMIES (SARTORIUS AND RECTUS FEMORIS AT THE LEVEL OF THE ASIS) WERE REQUIRED IN 21% OF PATIENTS WITH CP. SUBTROCHANTERIC FEMORAL OSTEOTOMY WAS REQUIRED TO RESTORE THE CENTER OF ROTATION TO THE LEVEL OF THE PALEOCOTYLE IN 7% OF PATIENTS WITH CP (1 PATIENT) AND IN 14% OF PATIENTS WITH DDH (8 PATIENTS). THE STUDY POPULATION HAD A MEAN AGE OF 30.3 YEARS IN THE CPHP GROUP AND 43.03 YEARS IN THE DDH GROUP AT TIME OF SURGERY; (CPHP 10 MALES/4 FEMALES AND DDH 16 MALES/ 42 FEMALES). FOLLOW-UP WAS CONDUCTED AT MINIMUM OF 12 MONTHS WITH A MEAN LENGTH OF FOLLOW-UP OF THREE YEARS. GONZÁLEZ-ADRIO, R.L., PACHA, D., ALIAGA-MARTÍNEZ, A. ET AL. TOTAL HIP ARTHROPLASTY AS RECONSTRUCTIVE TREATMENT IN PATIENTS WITH CEREBRAL PALSY: A COMPARATIVE STUDY OF POSTOPERATIVE OUTCOMES BETWEEN PATIENTS WITH DEVELOPMENTAL HIP DYSPLASIA AND CEREBRAL PALSY HIP DYSPLASIA. EUR J ORTHOP SURG TRAUMATOL 36, 155 (2026). HTTPS://DOI.ORG/10.1007/S00590-026-04701-5. THE LITERATURE REPORTED THAT SEVEN PATIENTS WITHIN THE CPHP GROUP AND EIGHT PATIENTS WITHIN THE DDH GROUP REQUIRED A BLOOD TRANSFUSION. PLEASE REFERENCE JOURNAL ARTICLE: HTTPS://DOI.ORG/10.1007/S00590-026-04701-5. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.