MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 150 MM LENGTH; ELBOW, PROSTHESIS

Catalog Number 00840004415

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign country: (b)(4).Concomitant medical products: humeral screw kit 2 humeral screws: cat: 00840009000, lot: 64160098.Ulnar component plasma sprayed size 5 75 mm length: cat: 00840002507, lot: 63399782.Customer has 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 report will be submitted.

Event Description

It was reported that the patient was noted to have ulnar and humeral component loosening in a radio graph review.A revision procedure has not been indicated at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: on (b)(6) 2019 post-operative: elbow mobilization delayed due to 3 surgeons involved in op.Nerve doc did exploration first, excised neuroma, provisional trim of damaged nerve ends=10cm gap.Nerve stim in theatre, decision taken not to graft today.For tendon trans.6 weeks post-operative: patient was not using right arm and experienced severe pain.Rom is at 50-100, with the elbow stable.Satisfied with results, only lifting 1 lb with operative arm.Xray showed no subsidence or osteolysis.6 months post-operative: patient experienced moderate pain with limited use of the right arm.Rom is at >100 with moderate instability.Not satisfied with results of surgery, lifting 5 lbs with operative arm.1-year post-operative: patient experienced moderate pain and was not using the right arm.Rom is at <50 with moderate instability.Not satisfied with results of surgery, lifting 3 lbs with operative arm.Patient was on disability.2-year post-operative: patient experienced severe pain and not using the right arm.Rom is at >100 with moderate instability.Lifting 3 lbs with operative arm and not working due to pain.Xray showed humeral and ulnar loosening with ulnar osteolysis.On (b)(6) 2021: 2 year visit x-rays showed loosening, no intervention to date.Device history record was reviewed and no discrepancies were found.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.

Event Description

Initial right total elbow performed on an unknown date due to trauma with unknown components and was later explanted due to aseptic loosening.The patient received a revision total elbow arthroplasty.At the 2 year follow up, x-rays showed humeral and ulnar loosening.It was reported the patient suffers with pain, instability, and limited rom.No intervention has been reported to date.

• Brand Name: HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 150 MM LENGTH
• Type of Device: ELBOW, PROSTHESIS
• 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: 12693305
• MDR Text Key: 278379785
• Report Number: 0001822565-2021-03104
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00840004415
• Device Lot Number: 62908109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 60 KG