MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EXPLOR 12X24 MM IMPLANT HEAD; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.Halverson et al."clinical outcomes of biomet explor modular radial head arthroplasty system" journal title.37:853-858.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

Event Description

Information was received based on review of a journal article manuscript titled ¿clinical outcomes of biomet explor¿ modular radial head arthroplasty system¿ which aimed to explore short-term outcomes of surgery using the explor modular radial head arthroplasty system, manufactured by legacy biomet.One 54 year old male was identified in the article that underwent radial head arthroplasty on an unknown date.Patient follow-up results provided at month 38 post-implantation indicates mild elbow instability, type o loosening, laterally wide joint symmetry, and overall non-anatomic alignment.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

Reported event was unable to be confirmed as the lot number of device involved in the incident is unknown.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 is required as no were trends identified.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.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2017-02355, 02686.

• Brand Name: EXPLOR 12X24 MM IMPLANT HEAD
• 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: 6456258
• MDR Text Key: 71598068
• Report Number: 0001825034-2017-02355
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• 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: 11-210042
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 54 YR