MDR event
Received May 30, 2013 · Event occurred Apr 7, 2011
Report 1719045-2013-01500 · MDR key 3138384
Device
Manufacturer
Synthes MonumentProduct problems
- Insufficient Device Problem Information
Patient
53 YR
- Unspecified Infection
- Pain
Narrative
Description of Event or Problem
(B)(4) STUDY PATIENT INITIALLY PRESENTED WITH A FRACTURE OF THE LEFT LATERAL CONDYLE OF THE TIBIA SUSTAINED IN A FALL ON (B)(6) 2011. PATIENT WAS IMPLANTED WITH A PROXIMAL TIBIA PLATE AND NORIAN DRILLABLE CEMENT ON (B)(6) 2011. PATIENT EXPERIENCED SEVERAL INFECTIONS AND CONTINUED TO COMPLAIN OF PAIN FOR TWO YEARS. THE PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REMOVAL OF HARDWARE AND REVISION TO A TOTAL KNEE REPLACEMENT. AT 6 WEEKS POST REVISION, THE PATIENT WAS STILL COMPLAINING OF PAIN. THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).
Additional Manufacturer Narrative
DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.
Additional Manufacturer Narrative
ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. COULD NOT BE DETERMINED WITHOUT A PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.