MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK HUMERAL STEM; PROSTHESIS, SHOULDER

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02735.

Event Description

It was reported that the comprehensive stem inserter would not disengage from the implant.Surgeon rocked it gently for 10 seconds and was able to get disengaged.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: a1, b4, b5, g4, g7, h2, h6, h10.Visual examination of the returned product identified indentation damage on black tip.Function check was done and the device functioned properly however the device does have some resistance when removing gage.No further measurements done as the black poly tip is damaged.Stem not returned.Part and lot identification are necessary for review of device history records, neither were provided for stem.A definitive root cause cannot 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.

Event Description

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

• Brand Name: UNK HUMERAL STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10283242
• MDR Text Key: 199891487
• Report Number: 0001825034-2020-02736
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMP PRIM STEM INSERTER CAT#407398 LOT#544080
• Patient Age: 87 YR