STRYKER Z1 TI-6AL-4V TITANIUM ALLOY FEMORAL STEM WITH BIOLOX D CERAMIC HEAD 36MM
Received Jun 3, 2026 · Event occurred Jun 9, 2025
Report MW5188867 · MDR key 25373735
Device
Generic name
Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calc
Manufacturer
Zimmer Biomet/ Zimmer, Inc.Patient
NA · Female
- Unspecified Infection
- Muscle Weakness/Atrophy
- Loss of Range of Motion
- Scar Tissue
- Synovitis
- Muscle/Tendon Damage
- Limb Pain
Narrative
Description of Event or Problem
TOTAL HIP REPLACEMENT WITH: SCREW TRID2 LP 6.5X20 - SN/A - LOG23034 10, Z1 HIP SYSTEM SIZE 4 CEMENTLESS COLLARED STANDARD OFFSET 12/14 TAPER HEAD FEMUR -3.5MM 12/14 SM 36MM HIP ACET BIOLOX D STERILE, SN/A - HIP SCREW SCRE TRID2 LP W 6.5X20 N/A N/A HIP, H HEAD EAD, FEMUR FEM -3.5MM ORAL 12/14 SM 36MM HIP ACET BIOLOX DSHELL ACET HIP SHELL TRID 2 TRIT SHEL ACET TRID CISTR48 - L 2 TRIT SN/A - ACET CLSTR48 LOG23034, ABUL 10 AR LINER HIP LINER TRIDENT X3 LINE TRIDENT OD 36MM R X3 0D ID 3.9MM ACET 36MM ID - SN/A - ABUL 3.9MM LOG23034 AR 10 SCREW TRID2 LP 6.5X35 - HIP SCREW SCRE TRID2 LP W 6.5X35 SN/A - LOG23034 10 SCREW TRID2 LP 6.5X20 - HIP SCREW SCRE TRID2 LP W 6.5X20 SN/A- LOG23034 10 71 HIP N/A N/A N/A CONTINUED THIGH, HIP AND LEG PAIN AFTER ONE YEAR. LIMITED RANGE OF MOTION AT ONE YEAR. TWO SYNOVIAL FLUID ASPIRATIONS SHOW WBC 13,760 AND LYMPHOCYTES 89%. SERUM TITANIUM 10 MCG/L. NEG FOR INFECTION AND RHEUMATOLOGY. NEG ESR AND CRP. MARS MRI (B)(6) 2025 DEDICATED IMAGES OF THE LEFT HIP DEMONSTRATE WELL FIXED FEMORAL COMPONENT. THE ACETABULAR CUP IS ALSO WELL FIXED. THERE IS MILD SYNOVIAL EXPANSION WITHOUT MR FINDINGS SPECIFIC FOR ACTIVE INFECTION OR AGGRESSIVE ADVERSE REACTION TO WEAR DEBRIS. A SMALL AMOUNT OF FLUID DISTENDS THE LEFT TROCHANTERIC BURSA. THERE IS NO ILIOPSOAS BURSITIS. THE SHORT EXTERNAL ROTATOR MUSCLES ARE ATROPHIC, AND THE TENDONS ARE SCARRED TO THE POSTERIOR PSEUDOCAPSULE. THE POSTERIOR FOOTPRINT GLUTEUS MEDIUS IS MILDLY TENDINITIS. THERE IS MILD TO MODERATE TENDINOSIS OF THE ANTEROLATERAL FIBERS GLUTEUS MEDIUS. THE GLUTEUS MINIMUS TENDON IS DISTORTED BY A RIDGE OF PROLIFERATIVE BONE ARISING FROM THE GREATER TROCHANTER, BUT THE TENDON IS INTACT. THE ILIOPSOAS TENDON IS NOT TORN, AND THE MUSCLE BULK IS MAINTAINED. THE RECTUS FEMORIS ORIGIN IS INTACT. NO STRESS REACTION IS SEEN AT THE SYMPHYSIS PUBIS. THE HAM [INVALID] ORIGINS ARE TENDINOTIC BILATERALLY. FOLLOW UP MRI ON (B)(6) CONTINUED TO SHOW SYNOVIAL FLUID LEAKING.