MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EPLOR 7X26 MM IMPLANT STEM WITH SCREW; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

A1 - cmp-0279293 d11 - medical product: explor 10x22 mm radial head, cat#: 11-210031, lot#: ni.E1 - initial reporter - the article was written by schuyler j halverson, mihir j desai and donald h lee.Halverson et al."clinical outcomes of biomet explor modular radial head arthroplasty system" journal title.37:853-858 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: 1825034-2017-02279, 02744.

Event Description

It was reported in a journal article that the patient underwent an elbow revision approximately 31 months post-implantation due to pain, loosening and for capsular release.No further information is available.

• Brand Name: EPLOR 7X26 MM IMPLANT STEM WITH SCREW
• 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: 6534558
• MDR Text Key: 74096456
• Report Number: 0001825034-2017-02744
• 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: Physician
• Type of Report: Initial
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• 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: 11-210062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• 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
• Treatment: SEE H10 SUMMARY
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR