MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS 60MM DST HML BDY LT; ELBOW, PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 05/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 211218, compr srs prox bdy - lg 42mm, unknown, unknown, unknown intercalary segment, unknown, unknown, unknown regenerex augment, unknown, unknown, unknown intramedullary stem, unknown, 211251, compr srs 60mm dst hml bdy lt, unknown, unknown, unknown pps augment, unknown, unknown, unknown seas head, 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.Device history record (dhr) review was unable to be performed as the 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.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 - 01570, 0001825034 - 2018 - 01571, 0001825034 - 2018 - 01572, 0001825034 - 2018 - 01573, 0001825034 - 2018 - 01574, 0001825034 - 2018 - 01575, 0001825034 - 2018 - 01576.Product location unknown.

Event Description

It was reported that a patient underwent a right elbow arthroplasty.Subsequently, the patient experienced inability to open jar, inability to do heavy chores, inability to carry bag, inability to wash back, inability to cut, inability to do recreational activities, inability to perform social activities, moderate limitations in daily activities, moderate pain, and moderate difficulty sleeping.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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 reviewed.Overall fit and alignment of the implants is grossly appropriate.No definite evidence for loosening or radiolucency.Of note, there is minimal bone seen along the humeral diaphysis which could be postsurgical or could represent evidence of osteolysis.This cannot be confirmed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the report event was not reported.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: COMPR SRS 60MM DST HML BDY LT
• 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: 7302816
• MDR Text Key: 101157501
• Report Number: 0001825034-2018-01574
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/23/2023
• Device Model Number: N/A
• Device Catalogue Number: 211251
• Device Lot Number: 706690
• Other Device ID Number: (01) 00880304850316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2013
• 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: 59 YR
• Patient Weight: 92