MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK RADIAL HEAD; ELBOW PROSTHESIS

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 Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Date of event: (b)(6) 2018.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,the patient underwent an open capsular release and manipulation of the joint eight month post primary implantation.Finally approximately two years four months post primary implantation underwent an arthroscopic release for ongoing limited rom and stiffness.

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.Reported event was confirmed by review of radiographs and medical records.Review of the available medical records identified the following: medical records on (b)(6) 2017: patient reports ongoing difficulties with stiffness since radial head replacement.No obvious swelling or deformity noted.Rom 80-110° flexion, 30° arc of prosupination.Neuro exam intact.No abnormalities noted on x-ray.Medical records on (b)(6) 2017: left elbow open capsular release for stiffness extension contracture.Preop rom 20-90° and supination of 30°.Tourniquet time 29 minutes.Posterior capsule extensively scarred, 1cm of olecranon resected, elbow manipulated with full rom and supination to 60-70°.Posterior release only, no anterior release medical notes for manipulation on (b)(6) 2019 were reviewed and identified: placed on cpm follow (b)(6) surgery for 2 weeks, rom improved to 115° flexion and 15° extension.By jan 1st, rom regressed to its original status before my 3rd surgery.(b)(6) 2019; left elbow examination under 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 radiographs provided were dated (b)(6), 2017.The report identifies alignment of the radial head and capitellum of humerus is maintained.The radial implant stem is not centrally positioned within the proximal radius and radiolucency at the most proximal bone/metal interface are noted.The bone quality is osteopenic.Root cause was unable to be determined.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.

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 (b)(4) 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: UNK RADIAL HEAD
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9834763
• MDR Text Key: 189350132
• Report Number: 0001825034-2020-01061
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 77