REFOBACIN BC R 1X40 US
Received Sep 10, 2025
Report 3006946279-2025-00104 · MDR key 23013709
Device
Generic name
Bone Cement, Antibiotic
Manufacturer
Biomet France S.a.r.l.Catalog number
110034355
Lot number
C0104V07BA
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Erythema
- Pain
- Loss of Range of Motion
- Rash
- Swelling/ Edema
- Erythema
- Pain
- Loss of Range of Motion
- Rash
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
(B))(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2A, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED AN ALLERGY TO CONTACT METAL AGENT AS CONTRIBUTING FACTOR OF EVENT. PATIENT UNDERWENT CONTINUAL PAIN STARTING SHORTLY AFTER SURGERY, THAT IS WORSENING WITH SOME RASH, HEAT, VERY LIMITED RANGE OF MOTION, STIFFNESS AND SWELLING. SEVER TIGHTNESS ALSO NOTICED, AS IF A TIGHT CAST IS AROUND THE KNEE. ADDITIONALLY, CONTRIBUTING CONDITION WAS NOTICED: OSTEOARTHRITIS. MILD INJURY WHERE KNEE POPPED WHILE CLIMBING STAIRS RESULTING IN PAIN AND SWELLING. MRI TAKEN AND PHYSICAL THERAPY PRESCRIBED FOR TWO MONTHS. PROGNOSIS ARTHRITIS. NO ISSUES AFTER THERAPY. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED THAT SINCE SURGERY HAS BEEN SUFFERING WITH ONGOING PAIN, REDNESS, SWELLING, RASH, DECREASED RANGE OF MOTION, STIFFNESS, AND TIGHTNESS OF KNEE. THE PATIENT HAS CONSULTED AN IMMUNOLOGIST WHO IS TESTING HER FOR ALLERGIES TO THE COMPONENTS AND BONE CEMENT. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.
Additional Manufacturer Narrative
(B)(4). D10: CONCOMITANT MEDICAL PRODUCTS: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD NITRIDED LEFT SIZE 5; ITEM NUMBER#: 42572605801; LOT NUMBER#: 65588780. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT USE WITH TIBIA SIZES C-D/CR FEMUR SIZES 4-5; ITEM NUMBER#: 42512100312; LOT NUMBER#: 65594820. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D; ITEM NUMBER#: 42532006701; LOT NUMBER#: 66891502. ALL POLY PATELLA CEMENTED 32 MM DIAMETER; ITEM NUMBER#: 42540000032; LOT NUMBER#: 67037346. 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.