MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP STD 36MM; REVERSE SHOULDER PROSTHESIS HEAD

Catalog Number 115310

Device Problems Migration or Expulsion of Device (1395); Naturally Worn (2988); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problem Metal Related Pathology (4530)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03295.

Event Description

It was reported that there was a reverse revision due to a clunk heard with patient during rom.Although patient had no pain prior to revising.Removed tray, poly, and glenosphere.Post of taper adapter inserted into glenosphere had significant amount of unusual wear as glenosphere was tilted while in the baseplate which caused metalosis on soft tissue.Cleaned up soft tissues and replaced taper adapter, glenosphere, poly, and tray.Attempts have been made and no additional information is available at this time.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial reports were forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial reports were forwarded in error and should be voided.

• Brand Name: COMP RVRS SHLDR GLNSP STD 36MM
• Type of Device: REVERSE SHOULDER PROSTHESIS HEAD
• 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: 13125125
• MDR Text Key: 283077994
• Report Number: 0001825034-2021-03296
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115310
• Device Lot Number: 290520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2019
• 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): Other