MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE E1 44-36 STANDARD HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problem Bacterial Infection (1735)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog# 113613, comprehensive primary stem 13 mm micro, lot# 421430.Catalog# 115370, comprehensive reverse tray co 44 mm, lot# 676680.Catalog# 115310, comprehensive reverse shoulder glenosphere standard 36 mm, lot# 719350.Catalog# 010000589, comprehensive reverse 25 mm baseplate ha + adapter, lot# 457470.Catalog# 115394, comprehensive reverse central 6.5 x 20 mm st/rst, lot# 305970.Catalog# 180553, comprehensive locking screw 3.5hex 4.75x30 st, lot# 641770.Catalog# 180551, comprehensive locking screw 3.5hex 4.75x20 st, lot# 041430.Catalog# 180552, comprehensive locking screw 3.5hex 4.75x25 st, lot# 571900.(b)(6).The device will not be returned for analysis; 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 reports: 0001825034-2018-03540, 0001825034-2018-03543, 0001825034-2018-03545, 0001825034-2018-03548.

Event Description

It was reported that a patient underwent an initial reverse total shoulder arthroplasty.Subsequently, the patient was revised due to infection.The patient developed wound complications and culture p.Acne infection.During revision surgeon revised the stem, tray, liner, glenosphere and taper, and completed the surgery by inserting antibiotic spacers.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

• Brand Name: COMPREHENSIVE REVERSE E1 44-36 STANDARD HUMERAL BEARING
• 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: 7541192
• MDR Text Key: 109163697
• Report Number: 0001825034-2018-03544
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK113121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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: Physician
• Device Expiration Date: 09/29/2022
• Device Model Number: N/A
• Device Catalogue Number: EP-115393
• Device Lot Number: 376840
• Other Device ID Number: (01) 00880304 54315 7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR