MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK HUMERAL COMPONENT; ELBOW PROSTHESIS

Catalog Number UNKNOWN

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

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The reported event was identified during review of a journal article.Mahdi siala md, pierre laumonerie md, abdellah hedjoudje md, stephanie delclaux md, nicolas bonnevialle md, phd, pierre mansat, md, phd.Outcomes of semiconstrained total elbow arthroplasty performed for arthritis in patients under 55 years old.Journal of shoulder and elbow surgery.

Event Description

A journal article was retrieved from journal of shoulder and elbow surgery (2019) that reported a retrospective, single-center study from france from 1998 to 2008 that looked at outcomes of semi constrained total elbow arthroplasty (tea) for patients with arthritis under 55 years old.A conrad-morrey tea was utilized on the patient.The study reported the patient to undergo a bipolar revision due to aseptic loosening and triceps failure.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.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.

• Brand Name: UNK HUMERAL COMPONENT
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10102673
• MDR Text Key: 195106044
• Report Number: 0001822565-2020-01909
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK ULNAR COMPONENT
• Patient Outcome(s): Hospitalization; Required Intervention