MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EXPLOR RADIAL STEM 8 X 28MM; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2016-05439 / 05440).

Event Description

Patient reported right elbow revision approximately one year post-implantation due to pain and loss of range of motion.Patient reported the prosthesis implanted was too long and too big and that synovial fluid was removed during the revision.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Provided x-rays were evaluated and the reported event was not confirmed.Appropriate size selection is done intraoperatively by using the native head size as a comparative measure to choose the arthroplasty size.Secondary signs of an oversized hardware component include widening of the ulnohumeral space.However the provided views do not allow for assessment of this joint space.The provided image suggests there may be lucency in the distal humerus (condylar region), but this may be artifactual in nature.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: EXPLOR RADIAL STEM 8 X 28MM
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6215537
• MDR Text Key: 63633595
• Report Number: 0001825034-2016-05439
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 11-210063
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention