MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM HUMERAL DISTAL PILOT 13 MM DIAMETER 130 MM LENGTH; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 00430901814, proximal provisional humeral stem 48 degrees 13/14 mm diameter, lot # unk, 00430104021, humeral head provisional 21 mm head height 40 mm spherical head diameter, lot # unk.Event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 06392, 0001822565 - 2018 - 06393.

Event Description

It was reported that during a primary shoulder arthroplasty, the surgeon reamed the humerus with a 13 mm reamer, and inserted the distal and proximal trial bodies.When the surgeon attempted to remove these devices, he was unsuccessful, and they were left in situ, along with the trial head.Devices have not been removed to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were update/corrected 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.A definite root cause cannot be determined with the information 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.

Event Description

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

• Brand Name: TM HUMERAL DISTAL PILOT 13 MM DIAMETER 130 MM LENGTH
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8075846
• MDR Text Key: 127337633
• Report Number: 0001822565-2018-06391
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00431201313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR