MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SEGMENTAL REVISION SYSTEM MODULAR STEM; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Perforation (2001)

Event Date 07/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products-comprehensive srs proximal body catalog#:211218 lot#:unk, and other unknown comprehensive reverse components.Multiple mdr reports were filed for this event, please see associated reports:0001825034 - 2017 - 05055.Customer has indicated that the device will not be returned for evaluation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient had initially underwent a right reverse shoulder arthroplasty.Subsequently, twenty one (21) days post-operatively, it was reported that the patient suffered a humeral fracture or perforation.The patient underwent cement extraction procedure from elbow for treatment and the issue was successfully resolved.The issue was reported to be not device related, but possibly procedure related.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the intial medwatch.The following sections were updated: (b)(6) date of this report - (b)(6) 2017; date received by manufacturer - aug 23, 2017 ; type of report - follow-up 1; if follow-up, what type - correction, additional information.The following sections were corrected: date of birth - (b)(6); date of event - (b)(6) 2015.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 05055 - 1.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Radiographs were reviewed but could not confirm the reported event.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no were trends identified.Root cause could not 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.

Manufacturer Narrative

(b)(4).

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.Radiographs were reviewed but could not confirm the reported event.Dhr was reviewed and no discrepancies were found.Root cause could not 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
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6725616
• MDR Text Key: 80457377
• Report Number: 0001825034-2017-05056
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 211241
• Device Lot Number: 309810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2018
• 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: 61 YR
• Patient Weight: 53