MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SEGMENTAL REVISION SYSTEM MODULAR STEM - 10X75MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Nerve Damage (1979)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: catalog# 211278, comprehensive segmental revision system seas humeral head 48x19, lot # unknown, catalog# 211228, comprehensive segmental revision system modular rgx aug - small, lot # unknown, catalog# 211222, comprehensive segmental revision system tumor body - 61mm, lot # unknown.(b)(6).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 will be submitted.Multiple mdr reports were filed for this event, please see associated reports:0001825034-2018-03744, 0001825034- 2018-03745, 0001825034-2018-03747.Remains implanted.

Event Description

It was reported that during a total humerus arthroplasty patient suffered an injury to a nerve causing incomplete axillary nerve dysfunction.The patient also suffered from a hematoma two (2) days post-operatively.The patient was placed on antibiotics to treat the hematoma.Both of these issues were resolved.No further complications during procedure were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: catalog# 211228, comprehensive segmental revision system modular rgx aug small, lot # 664510 catalog# 211222, comprehensive segmental revision system tumor body 61mm, lot # 543430 catalog# 211278, comprehensive segmental revision system seas humeral head 48x19, lot # 886950.Foreign: canada.Complaint sample was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined.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 - 10X75MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7560485
• MDR Text Key: 109773261
• Report Number: 0001825034-2018-03746
• 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: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 211232
• Device Lot Number: 215950
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 33