MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problem Unspecified Infection (1930)

Event Date 03/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product code: phx.Unique identifier (udi) #: (b)(4).Concomitant medical products: item # 115378, comp rvs tray +10mm co 44mm, lot #905990.Item # 180550, comp lk scr 3.5hex 4.75x15 st, lot # 331030.Item # 180554, comp lk scr 3.5hex 4.75x35 st, lot # 028240.Item # 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 017540.Item # 115310, comp rvrs shldr glnsp std 36mm, lot # 961680.Item # 180550, comp lk scr 3.5hex 4.75x15 st, lot # 135680.Item # 115396, comp rvs cntrl 6.5x30mm st/rst, lot # 391730.Item # 406669, stn pn thd tip.125x2.5in 2pk, lot # 354400.Item # 113635, comp primary stem 15mm mini, lot # 231180.Legal notification.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09193, 0001825034-2018-09195, 0001825034-2018-09196, 0001825034-2018-09197, 0001825034-2018-09198, 0001825034-2018-09199, 0001825034-2018-09200, 0001825034-2018-09201, 0001825034-2018-09202.

Event Description

It was reported that approximately three (3) months post implantation, the patient underwent a revision to have the shoulder prosthesis removed with irrigation and debridement and the placement of an antibiotic spacer.It is further alleged that the patient continued to have antibiotic treatment for infection from the 2nd revision, until present time.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Op notes dated for this revision note that as soon as the surgeon opened through the deltoid fascia, they encountered cloudy fluid, which was cultured with attempted reduction of the shoulder.The humeral component was still impinging with the intact inferior glenoid, as was expected from the radiographs.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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: COMPREHENSIVE REVERSE HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7946927
• MDR Text Key: 123076592
• Report Number: 0001825034-2018-09194
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 884300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR