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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2020-02210.

Event Description

It was reported by the (b)(6) that a patient underwent a left shoulder hemi arthroplasty on an unknown date.Subsequently, the patient was revised due to sepsis.A tm humeral stem with a bf offset humeral head were explanted.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: zone of circumferential periprosthetic lucency surrounding the cement throughout the imaged humerus, extending from the level of the humeral neck to the diaphysis and seen circumferentially.Hardware and cement otherwise intact.No fracture of the bones detected.Fit and alignment appear normal.Bone quality appears normal.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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 TM HUMERAL STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10189160
• MDR Text Key: 196265338
• Report Number: 0001822565-2020-02209
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK BF HUMERAL HEAD CAT#NI LOT#: NI.; UNK BF HUMERAL HEAD CAT # NI, LOT # NI.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR