UNKNOWN FEMUR
Received Mar 4, 2026 · Event occurred Jan 28, 2025
Report 0001822565-2026-00707 · MDR key 24506311
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Pain
- Loss of Range of Motion
- Joint Laxity
- Swelling/ Edema
- Aseptic loosening
Narrative
Description of Event or Problem
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS REPORT IS A DUPLICATE OF (B)(4) 3007963827-2026-00079. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. IF ADDITIONAL INFORMATION IS TO BE RECEIVED CONCERNING THE REPORTED EVENT, A SUPPLEMENTAL MDR WILL BE SUBMITTED UNDER 3007963827-2026-00079.
Additional Manufacturer Narrative
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS REPORT IS A DUPLICATE OF (B)(4) 3007963827-2026-00079. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. IF ADDITIONAL INFORMATION IS TO BE RECEIVED CONCERNING THE REPORTED EVENT, A SUPPLEMENTAL MDR WILL BE SUBMITTED UNDER 3007963827-2026-00079.
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT A REVISION APPROXIMATELY 1.5 YEARS POST IMPLANTATION DUE TO PAIN, SWELLING/EDEMA, DECREASED ROM, GRINDING, AND INSTABILITY. DURING THE REVISION IT WAS NOTED THE SCREW BETWEEN STEM AND TIBIA NOT TIGHTENED ALL THE WAY WITH THE HEAD NOT BELOW THE SURFACE OF THE TIBIA PLATE. NO FURTHER INFORMATION PROVIDED.
Additional Manufacturer Narrative
(B)(4). D10: UNKNOWN ART SURFACEL, UNKNOWN PN/LN. UNKNOWN TIBIA, UNKNOWN PN/LN. G2: FOREIGN - EVENT OCCURRED IN SOUTH AFRICA. SUGGESTED COMPONENT CODE: MECHANICAL (G04) ¿ FEMUR. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.