MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOMXL RETENTIVE +3 MM HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: 113650, comprehensive humeral stem, 887520; 010000589, comprehensive mini baseplate & taper adaptor,314230; 115320, versa-dial glenosphere standard, 073170; 115370, cobalt chrome standard humeral tray, 005740.The investigation is in process.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 - 08529, 0001825034 - 2018 - 08531, 0001825034 - 2018 - 08532, 0001825034 - 2018 - 08534.Not returned to manufacturer.

Event Description

It was reported the patient underwent a left reverse total shoulder arthroplasty revision surgery due to unknown reasons, approximately three (3) weeks following prior shoulder revision.Attempts have been made and no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARCOMXL RETENTIVE +3 MM HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7812877
• MDR Text Key: 118124276
• Report Number: 0001825034-2018-08533
• Device Sequence Number: 1
• Product Code: PAO
• 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: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: N/A
• Device Catalogue Number: XL-115368
• Device Lot Number: 976440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR