MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Damage to Ligament(s) (1952); Pain (1994)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: (b)(4).Concomitant medical products: 115734, compr nano hmrl pps 34mm, lot # 985710; 113032, versa-dial 42x18x46 hum head, lot # 997910; pt-113950, pt hybrid glen post regenerex, lot # 464270.Report source: event occurred in the (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01533, 0001825034 - 2019 - 01534.

Event Description

It was reported that approximately 4 years post implantation, the patient was revised to a r reverse total shoulder system due to a rotator cuff tear.Attempts have been made and no further information has been provided.

Manufacturer Narrative

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

Event Description

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

• Brand Name: VERSA-DIAL/COMP TI STD TAPER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8484384
• MDR Text Key: 140958097
• Report Number: 0001825034-2019-01532
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 330730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 83