MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X25MM ST/RST; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Difficult to Advance (2920); Noise, Audible (3273); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 09/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant products: item # 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 277580; unknown central screw.(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09399.

Event Description

It was reported that during a primary reverse shoulder procedure, the 30 mm central screw did not seem to fully seat into the baseplate.The screw was squeaking and seemed to jam.The surgeon removed the screw, and used a new one, but had the same problem.The surgeon was able to push the new screw in with force, past the squeaking part, and then the screw seemed to seat another millimeter or so.Attempts have been made and no further information has been provided.

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.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definite root cause cannot be determined with the information 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.

Event Description

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

• Brand Name: COMP RVS CNTRL 6.5X25MM ST/RST
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7942966
• MDR Text Key: 123057367
• Report Number: 0001825034-2018-09398
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: PK132239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115395
• Device Lot Number: 931680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention