MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN COMPREHENSIVE SEGMENTAL REVISION SYSTEM HUMERAL HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices - comprehensive segmental revision system 10mm x 150mm modular stem catalog #: 211243 lot #: 011130; comprehensive standard taper adaptor catalog #: 118001 lot #: 084180; comprehensive segmental revision system modular regenerex augment with screws catalog #: 211229 lot #: 916390; comprehensive reverse glenosphere catalog #: 115320 lot #: 677350.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded after it was explanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.This report is number 1 of 2 mdrs filed for the same patient (reference 0001825034-2017-05384).

Event Description

It is reported that the patient underwent a shoulder arthroplasty revision with removal of the hemiarthrodesis of the proximal humerus due to failure of soft tissue adherence of the rotator cuff nine (9) months post-operatively.The patient was revised to a reverse segmental revision system (srs) proximal humerus.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being filed to relay additional information.The following fields were updated.

Event Description

It is reported that the patient underwent a shoulder arthroplasty revision with removal of the hemiarthrodesis of the proximal humerus due to failure of soft tissue adherence of the rotator cuff nine (9) months post-operatively.The patient was revised from an unknown comprehensive segmental revision system (srs) to a comprehensive reverse segmental revision system (srs) proximal humerus.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was confirmed by review of x-rays provided.The review identified, "high-riding humeral head with narrowing of the subacromial space indicative of either a full thickness rotator cuff tear or failure of rotator cuff adherence." device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Complaint history review cannot be performed without product identification.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.

• Brand Name: UNKNOWN COMPREHENSIVE SEGMENTAL REVISION SYSTEM HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6757619
• MDR Text Key: 81516430
• Report Number: 0001825034-2017-05383
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2018

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: Physician
• Device Expiration Date: 02/28/2024
• Device Model Number: N/A
• Device Catalogue Number: 211221
• Device Lot Number: 182240
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 08/01/2017
• Supplement Dates Manufacturer Received: 01/09/2018; 03/06/2018
• Supplement Dates FDA Received: 02/08/2018; 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 66