MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE HUMERAL STEM TRIAL 10 MM; TEMPLATE FOR CLINICAL USE

Model Number N/A

Device Problem Off-Label Use (1494)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a shoulder arthroplasty, a trial humeral stem was implanted.The issue was identified during the procedure, however the cement had already set and the trial stem could not be removed.The procedure was completed with the trial stem implanted.No patient consequences have been reported as a result.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

Concomitant medical products- unk glenoid component, unk humeral head.Report source: (b)(6).Reported event was unable to be confirmed as 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 is determined to be a deviation from surgical technique (use error).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: COMPREHENSIVE HUMERAL STEM TRIAL 10 MM
• Type of Device: TEMPLATE FOR CLINICAL USE
• 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: 6904785
• MDR Text Key: 88230240
• Report Number: 0001825034-2017-07613
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 31-406910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 01/08/2018; 05/04/2018
• Supplement Dates FDA Received: 02/01/2018; 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 85 YR