MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SEAS AUGMENT; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tingling (2171)

Event Date 09/23/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see associated reports: 0001825034 - 2018 - 01409, 0001825034 - 2018 - 01410, 0001825034 - 2018 - 01411, 0001825034 - 2018 - 01412, 0001825034 - 2018 - 01413, 0001825034 - 2018 - 01414.Concomitant medical products: 211224 compr srs ic seg - 30mm, unknown lot, 211237 compr srs mod stem - 10x100mm, unknown lot, 211253 compr srs 50mm dst hml bdy rt, unknown lot, unknown part/lot; proximal body, regenerx augment, pps augment.Report source: foreign.The event occurred in the (b)(6).Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.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 as the necessary information to adequately investigate the reported event was not provided.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.Device remains implanted.

Event Description

It was reported that the patient found it severely difficult to open jar, do heavy chores, carry bag, wash back, cut grass, perform social activities, and perform daily activities.The patient experienced moderate pain and moderate tingling.Attempts have been made and no further information has been made available at this time.

Manufacturer Narrative

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

• Brand Name: UNKNOWN SEAS AUGMENT
• 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: 7306172
• MDR Text Key: 101270667
• Report Number: 0001825034-2018-01415
• Device Sequence Number: 1
• Product Code: JDB
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 74 YR
• Patient Weight: 78