MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISC LT SEG ULNA 5X115MM; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Ambulation Difficulties (2544)

Event Date 03/18/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 211226, compr srs ic seg - 90mm, 067980, 211237, compr srs mod stem - 10x100mm, 753020, 211250, compr srs 50mm dst hml bdy lt, 155910, unknown, unknown discovery humeral condyle kit, unknown.Report source, foreign - the event occurred in the (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.X-rays were submitted to mmi for review.Overall fit and alignment of the implants is appropriate on most images.No obvious evidence for wear.Lucency is seen along the humeral component consistent with loosening.Dhr was reviewed and no discrepancies were found.Root cause could not be determined with information available.Lucency suggestive of loosening can be a contributing factor to the adl difficulty.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 01697, 0001825034 - 2018 - 01698, 0001825034 - 2018 - 01699, 0001825034 - 2018 - 04243.Product location unknown.

Event Description

It was reported that the patient reported being unable to do the following; open a jar, heavy chores, recreational activities, carry a bag, and wash back which limited daily activities.Subsequently, the patient was revised due to loosening and/or implant migration.No further information has been made available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient underwent a left elbow surgery.As part of the study, the patient underwent a left elbow revision procedure.Subsequently, during a six month and one year follow up appointment, the patient reported being unable to do the following; open a jar, heavy chores, recreational activities, carry a bag, and wash back which limited daily activities.Subsequently, the patient was revised due to loosening and/or implant migration.No further information has been made available at this time.

• Brand Name: DISC LT SEG ULNA 5X115MM
• Type of Device: PROSTHESIS, ELBOW
• 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: 7633644
• MDR Text Key: 112164832
• Report Number: 0001825034-2018-04244
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: CP562016
• Device Lot Number: 503320
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 82