MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHDR GLEN BSPLT +HA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Date 04/06/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

The patient reported a revision, stating "the ball on the implant did not fit in the rotator cup properly" post primary total reverse shoulder replacement.No further information has been made available.

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.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.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: COMP RVRS SHDR GLEN BSPLT +HA
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 6933511
• MDR Text Key: 88956391
• Report Number: 0001825034-2017-08134
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 115330
• Device Lot Number: 973870
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 10/25/2017
• Supplement Dates FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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