MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH RIGHT; ELBOW, PROSTHESIS

Catalog Number 00840002407

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 04/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: humeral screw, cat: 00840009000, lot: 62875490, humeral component, cat: 00840004410, lot: 62918648, articulation kit, cat: 00840009400, lot: 63020195.Foreign report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that a patient underwent a right elbow revision due to loosening of the ulna component and there is suspicion of infection.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

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

The patient was revised due to pain and aseptic loosening of the ulnar component.All components were removed and replaced without complications.

Event Description

No further event information 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, d10, g4, g7, h1, h2, h3, h6, h10.Reported event was confirmed by review of x-rays provided.Visual examination of the returned product identified the lot numbers of the humeral stem and the poly pieces of the articulation kit could be verified.The ulnar stem lot could not be verified as there was bone cement still attached and the lot of the one humeral screw was not etched on the part.One of the humeral screws appears to not be returned.Cosmetic inspection of the parts found them to have wear marks and damages such as nicks, gouges and heave scratches.No conclusions can be made as it is unknown if the damages happened in-vivo or during the explant process.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: aseptic loosening with no evidence of infection.Ulnar component completely loose, easily removed.Humeral component well-fixed and removed.No significant findings noted.New products placed without complication.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fractured cement component of arthroplasty.There is note of periprosthetic lucency surrounding the cement and bone.However, assessment for loosening would be best evaluated by comparison to prior radiographs to evaluate for progression/worsening of findings and lack of these findings on the immediate postoperative images.Moderate amount of soft tissue swelling seen along the likely lateral aspect of the elbow on the frontal view.Chronic bone resorption of the proximal radius including the radial neck and head noted.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH RIGHT
• Type of Device: ELBOW, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10034198
• MDR Text Key: 190188168
• Report Number: 0001822565-2020-01652
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00840002407
• Device Lot Number: 63019947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 75