MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS 50MM DST HML BDY LT; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Sleep Dysfunction (2517)

Event Date 04/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 114818, disc ulna 3 x 155 mm lt w/brng c, 869410.Unknown, unknown comprehensive srs mod stem, unknown.Unknown, unknown comprehensive srs flange, unknown.Unknown, unknown discovery humeral condyle kit, unknown.(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.Bone quality is osteopenic.Multiple images which demonstrate punctate hyperdensities within the soft tissues at the level of the elbow which could suggest metallosis.Dhr was reviewed and no discrepancies were found.Root cause could not be determined with information available.A possible contributing factor to the pain could be the metallosis.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 - 04143, 0001825034 - 2018 - 04144, 0001825034 - 2018 - 04145, 0001825034 - 2018 - 04146.

Event Description

It was reported the patient reported moderate difficulty sleeping due to pain, being unable to do heavy chores, to carry a bag, to wash back, to cut, to do recreational activities, and extremely limited with daily activities.Patient also indicated during the 6 month follow up moderate arm, shoulder, or hand pain, and no pain at the one year follow up.Attempts have been made and no further information has been provided.

• Brand Name: COMPR SRS 50MM DST HML BDY LT
• 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: 7616128
• MDR Text Key: 111570745
• Report Number: 0001825034-2018-01623
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK111746
• 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
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 211250
• Device Lot Number: 430570
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2013
• 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): Other
• Patient Age: 51 YR
• Patient Weight: 80