MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 6X150MM; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 06/30/2014

Event Type  Injury  

Manufacturer Narrative

(b)(6).Medical devices: (b)(4), compr srs 60mm dst hml bdy rt, (b)(4).Report source, foreign ¿ events occurred in (b)(6).Customer has been indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 09983.

Event Description

It was reported that the patient underwent right elbow arthroplasty.Subsequently, the patient underwent a second revision of the distal srs due to malpositioning of the humeral component.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was confirmed by review of the provided x-rays.The x-rays were reviewed by the operative surgeon and identified stem malposition in the immediate postoperative x-rays.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause determined to be component was malpositioned during the procedure and required subsequent revision.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: COMPR SRS MOD STEM - 6X150MM
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7005520
• MDR Text Key: 91185042
• Report Number: 0001825034-2017-09984
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 211241
• Device Lot Number: 046230
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2012
• 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
• Patient Age: 69 YR
• Patient Weight: 77