MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 14X24 MM IMPLANT HEAD; PROSTHESIS, ELBOW

Catalog Number 11-210043

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).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.Product remains implanted.

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

No additional event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated:b4, b5, g4, g7, h1, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.Radiographs were provided and the following results were identified: manipulation notes: 16-jan-2019; left elbow examination under the regional block with manipulation due to left elbow contracture elbow brought to full extension until adhesions were felt to lyse and release, able to achieve full extension, flexion to 145°, full pronation and supination to 80°, cortisone injections provided, procedure completed without complication (no product exchange) contributing factors of event: traumatic injury fracture-dislocation (terrible triad injury) left elbow orif with lateral ligament repair and radial head replacement previous open capsular release with manipulation previous arthroscopic lysis of adhesions root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

Manufacturer Narrative

D4: udi# (b)(4).D11: 11-210063 explor 8x28mm impl stem w/scr 561880 3322-020 depuy bone cement 8195909.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 - 03709.

Event Description

No additional event information received at the time of this report.

Manufacturer Narrative

The events under complaints (b)(4) 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 cmp-0581544 and medwatch# 0001825034 - 2020 - 00923 - 2.

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.

• Brand Name: EXPLOR 14X24 MM IMPLANT HEAD
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9865488
• MDR Text Key: 189449030
• Report Number: 0001825034-2020-01260
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 11-210043
• Device Lot Number: 504020
• 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