MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BROACH; INSTRUMENTS, SHOULDER

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Infiltration into Tissue (1931)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 113628, comp primary stem 8mm mini mini, 902250.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02795.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that after preparing the humeral canal with a size 9 broach, the size 8 mini stem was selected for implantation, as there is a 1.5mm press-fit.Stem was introduced, and had absolutely no press-fit.The size 8 mini stem was removed.The procedure was completed by rasping lightly to size 10, and inserting a size 9 mini stem.Attempts have been made to gain information, however no additional information was made available.

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The returned stem was conforming to print specifications.The broach was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The root cause of the reported issue is attributed to use error.Per the surgical techniques, "select a humeral stem which matches the final broach/trial used.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: UNKNOWN BROACH
• Type of Device: INSTRUMENTS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8750962
• MDR Text Key: 149756527
• Report Number: 0001825034-2019-02857
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• 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: 407308
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other