MAUDE Adverse Event Report: ZIMMER BIOMET, INC. B/F GLENOID COMPONENT PEGGED 52 MM DIAMETER ARTICULAR SURFACE; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Hematoma (1884); Pain (1994)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical products: item # 00430001313, modular humeral stem 13 mm stem diameter 130 mm stem length, lot # 62052450.Item # 00430205219, offset modular humeral head 19 mm head height 52 mm spherical head diameter, lot # 61966672.(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05736, 0001822565-2018-05738.

Event Description

It was reported that following removal of a fractured cerclage wire, the patient experienced the formation of hematoma approximately twelve (12) days post-op.During follow-up visits approximately three (3) weeks and two (2) months after the cerclage wire removal, the hematoma was smaller and the patient had full range of motion of shoulder.However, the patient is still experiencing some ongoing shoulder pain.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were update/corrected updated: reported event was unable to be confirmed due to limited information received from the customer.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 GLENOID COMPONENT PEGGED 52 MM DIAMETER ARTICULAR SURFACE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7968967
• MDR Text Key: 123817700
• Report Number: 0001822565-2018-05737
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

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 Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00430008700
• Device Lot Number: 61626329
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 103