MAUDE Adverse Event Report: ZIMMER BIOMET, INC. B/F OFFSET MODULAR HUMERAL HEAD 17 MM HEIGHT 46 MM SPHERICAL DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the products remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional concomitant medical products: 00434900813, humeral stem, lot 11013051, 00434903700, dual taper insert, lot 62945973.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 06035, 0001822565 - 2018 - 06036.

Event Description

It was reported that approximately one (1) month post-revision of the l shoulder, the patient reported pain, impaired posture, stiffness, decreased range of motion and strength, abnormal scapular mechanics, as well as a decrease in l arm strength and ability to perform adls, requiring pt.Symptoms were still reported to be present approximately four (4) months post-operatively.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event was confirmed by review of medical records.Physical therapy notes were provided from the patient's post-revision visits, which confirm her limited range of motion, pain, and strength abnormalities.Device history record (dhr) was reviewed and no discrepancies were found.A definite root cause cannot be determined with the information provided.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: B/F OFFSET MODULAR HUMERAL HEAD 17 MM HEIGHT 46 MM SPHERICAL DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8045612
• MDR Text Key: 126359594
• Report Number: 0001822565-2018-06034
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• 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: 00430204617
• Device Lot Number: 62763415
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 91