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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 115310, comp rvrs shldr glnsp std 36mm 129260; 113629, comp primary stem 9mm mini, 979660; 115370, comp rvs tray co 44mm, 596600; 010000589, comp rvrs 25mm bsplt ha+adptr, 592930;  180558, comp nlk scr 3.5hex 4.75x20 st, 860890; 180560, comp nlk scr 3.5hex 4.75x30 st, 018440; 115397, comp rvs cntrl 6.5x35mm st/rst, 569900.The investigation is in progress.Once the investigation is completed a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -06009; 0001825034 -2018 -06014; 0001825034 -2018 -06025; 0001825034 -2018 -06029.

Event Description

It was reported that the patient underwent a reverse total shoulder arthroplasty, and was revised due to unknown reasons approximately five (5) months post-implantation.No additional information is available at this time.

Manufacturer Narrative

Upon reassessment of the reported based on additional information.It was determined that the product did not contribute to the reported event.The initial report submitted should be voided.

Event Description

Upon reassessment of the reported based on additional information.It was determined that the product did not contribute to the reported event.The initial report submitted should be voided.

• Brand Name: COMPREHENSIVE REVERSE E1 HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7754454
• MDR Text Key: 116209514
• Report Number: 0001825034-2018-06031
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK113121
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: N/A
• Device Catalogue Number: EP-115393
• Device Lot Number: 734030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2019
• 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: 68 YR