FDA Adverse Event Injury Summary report: N

BIONX IMPLANT

MDR report key: 235471 · Received August 6, 1999

Report

Report Number
MW1016915
Event Type
Injury
Date Received
August 6, 1999
Date of Event
April 22, 1999
Report Date
August 6, 1999
Manufacturer
BIONX IMPLANTS, INC.
Product Code
MAI
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PT HAD SUDDEN EPISODE OF ACUTE PAIN AND SEVERE LOSS OF RANGE OF MOTION IN SHOULDER. PREOPERATIVE DIAGNOSIS: PROBABLE FAILED IMPLANT, LEFT SHOULDER. POSTOPERATIVE DIAGNOSIS: FAILED IMPLANT WITH LOOSE BODIES AND SYNOVITIS. PROCEDURE PERFORMED: GLENOHUMERAL DEBRIDEMENT, REMOVAL OF LOOSE BODIES AND DEBRIDEMENT OF LABRUM. ANESTHESIA: GENERAL. THIS PT HAD A PREVIOUS ARTHROSCOPIC BANKART USING A BIONICS ABSORBABLE TACK. HE DID WELL FOR SEVERAL MONTHS AND THEN, SUDDENLY, HE DEVELOPED AN ACUTE EPISODE OF SEARING PAIN IN HIS SHOULDER. AN MRI WAS PERFORMED AND CONFIRMED A LOOSE, FAILED IMPLANT IN THE SHOULDER. FINDINGS: THERE WERE TWO LARGE PIECES OF THE 8MM HEAD LOOSE IN THE GLENOHUMERAL JOINT. THERE WAS SOME MILD INFLAMMATION. THERE WAS A SMALL TEAR OF THE LABRUM. THE LABRUM THAT HAD BEEN REPAIRED WITH THE TACK WAS INTACT. PROCEDURE: WITH THE PT UNDER GENERAL ANESTHESIA IN THE LATERAL POSITION, THE SHOULDER WAS PREPPED AND DRAPED IN STERILE MANNER WITH THE LEFT ARM IN ABDUCTION AND TRACTION. THE ARTHROSCOPE WAS INTRODUCED POSTERIORLY INTO THE GLENOHUMERAL JOINT WITH INFLOW THROUGH THE SCOPE. THE INSTRUMENTATION WAS DONE THROUGH THE ANTEROSUPERIOR PORTAL. THE JOINT WAS INSPECTED IN STANDARD MANNER. THE HUMERAL HEAD WAS INTACT. THE ANTERIOR LABRUM THAT HAD BEEN REPAIRED WAS INTACT. THE ANTERIOR CAPSULE WAS INTACT. THERE WAS SOME FRAYING OF THE ANTERIOR LABRUM AND THERE WAS SOME HYPERTROPHIC SYNOVIUM. THE SUPERIOR LABRUM HAD A SMALL TEAR AND THERE WAS A MILD TEAR OF THE POSTERIOR LABRUM. THE LOOSE BODIES WERE IDENTIFIED. THERE WAS A LOOSE HEAD THAT APPEARED TO BE ABOUT HALF OF THE HEAD OF THE IMPLANT. THE OTHER HALF WAS ALSO FOUND LATER IN THE SHOULDER. THE SHAVER WAS INTRODUCED AND DEBRIDEMENT OF THE LABRUM WAS DONE ALONG WITH DEBRIDEMENT OF THE SYNOVIUM. THE GRASPER WAS USED TO GRASP THE PIECE AND REMOVE IT AND IT WAS SENT TO PATHOLOGY FOR GROSS EVAL. THE OTHER PIECE WAS ALSO FOUND, GRASPED AND REMOVED. THERE WERE SOME SMALL FRAGMENTS OF THE IMPLANT THAT WERE SEEN IN THE SHOULDER AND THESE WERE SUCKED OUT WITH THE SHAVER. THE SHAVER WAS USED TO CONTINUE TO DEBRIDE THE JOINT. THE LABRUM WAS DEBRIDED ADEQUATELY. SYNOVIUM WAS DEBRIDED. THE SHOULDER WAS THOROUGHLY INSPECTED AND ALL FOLDS OF TISSUE WERE THOROUGHLY INSPECTED TO MAKE SURE THAT THERE WERE NO FURTHER LOOSE PIECES. THE INSTRUMENTS WERE REMOVED. MARCAINE WAS INSTILLED INTO THE JOINT. THE WOUNDS WERE SUTURED AND DRESSING APPLIED. THE PT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BIONX IMPLANT Implant BANKART TACK MAI BIONX IMPLANTS, INC. * 178

Patients

Seq Age Sex Outcome Treatment
1 31 YR Other| S