MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 8X28MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Catalog Number 11-210063

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Loss of Range of Motion (2032); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-210043 explor 14x24 mm implant head 504020.3322-020 depuy bone cement 8195909.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 - 2020 - 01260 - 2.

Event Description

It was reported that the patient underwent an initial left orif, lateral ligament repair, and radial head replacement.Subsequently, post three surgical interventions within two years, the patient continues to experience difficulty with stiffness and range of motion without relief.No additional patient consequences were reported.

Event Description

Upon receipt of additional information, it has been determined that this device has been reported as a duplicate.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

The events under complaints (b)(6), (b)(6), (b)(6), (b)(6), are a continuation of the same complication resistant to medical/surgical interventions, are within a short timeframe, and no product has been exchanged.This device has been reported under (b)(6), and medwatch# 0001825034 - 2021 - 00058.

• Brand Name: EXPLOR 8X28MM IMPL STEM W/SCR
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10643827
• MDR Text Key: 210382148
• Report Number: 0001825034-2020-03709
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K040611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 11-210063
• Device Lot Number: 561880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 77