MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SEGMENTAL REVISION SYSTEM MODULAR STEM - 8X100MM; PROTHESIS, SHOULDER

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #211266, comprehensive segmental revision system anti rotation ic seg-30mm, lot #180700.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital retaining the device.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03469.Hospital retained device.

Event Description

It was reported that the patient underwent a re-implantation elbow arthroplasty revision procedure.During the surgery, after assembling the ic segment and stem, the surgeon decided to add a flange.The taper and stem would not disengage in order to add this component, and there were no other pieces available.There was a 2 hour delay in the procedure, while the patient was under anesthesia, to get a replacement piece.No further patient consequences were reported.Attempts have been made and no other information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.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: COMPREHENSIVE SEGMENTAL REVISION SYSTEM MODULAR STEM - 8X100MM
• Type of Device: PROTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7530984
• MDR Text Key: 108850036
• Report Number: 0001825034-2018-03470
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 211236
• Device Lot Number: 765500
• Other Device ID Number: (01) 00880304 54048 4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2018
• 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: 52 YR
• Patient Weight: 68