MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 42 DEGREES 10 MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: product , lot or serial, description, d4 primary di: 00-4302-046-27, lot: 62433463, bf offset hum head 27mm x 46mm; 00889024265721;  00-4302-040-46, lot: 63344409, bf 40mm pegged glenoid w/46mm; 00889024265646;  00-4342-110-13, lot: 62867558, tm humeral stem 42 deg; 00889024268630.  multiple mdr's were filed for this event.Please see 0001822565 - 2019 - 01255, 0001822565 - 2019 - 02821.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported that patient underwent left shoulder arthroplasty (b)(6) 2017 and subsequently is experiencing pain and alleges developing crps and sjorgens disease within three weeks of the procedure.The patient has not been revised and is requesting material composition of the implanted devices.No further information is available at the time of this reporting.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No device was returned.Medical record were reviewed but was unable to confirm the report.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is unknown.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: HUMERAL STEM 42 DEGREES 10 MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8767762
• MDR Text Key: 150278338
• Report Number: 0001822565-2019-02823
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K041549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434211013
• Device Lot Number: 62867558
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 09/12/2019
• 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: 64 YR