MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM PRIMARY STANDARD LENGTH SHOULDER STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has not yet indicated if the product will be returned to zimmer biomet for investigation.The devices remain implanted at this time.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: 0001825034-2017-02526/ 0001825034-2017-02553/ 0001825034-2017-02554/ 0001825034-2017-02556/ 0001825034-2017-02557.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-02806/ mdt33098/ 1825034-2016-03470/ 1825034-2016-04831/ 0001825034-2016-02804/ 0001825034-2016-02805.Medical products-comprehensive reverse shoulder glenosphere catalog: 115310, lot#868870; versa dial taper catalog#:118001, lot#:378870; comprehensive cntrl, catalog#: 1153696, lot#:424640; tray catalog#:115370, lot#:unk; humeral bearing, catalog#:xl-115363, lot#:369090; versa dial taper, catalog#:118001, lot#:707740; shoulder glenoid baseplate, catalog#:115330 lot#:422790; stem catalog#:113632, lot#:485330; comprehensive central screw, catalog#: 115383, lot#:787000; humeral bearing, catalog#:xl-115363, lot#:950910; reverse shoulder, catalog#:115310, lot#:921470; humeral bearing, catalog#: xl-115363, lot#:450680.

Event Description

It is reported the patient is experiencing pain and headaches approximately eight months following revision shoulder procedure.No revision procedure has been indicated to date.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product: comprehensive reverse shoulder glenosphere catalog: 115310, lot#868870.Versa dial taper catalog#:118001 lot#:378870.Comprehensive reverse tray, catalog#: 115375, lot#: 360190.Comprehensive reverse humeral bearing catalog#:xl-115363 lot#:369090.Comprehensive reverse shoulder glenoid baseplate catalog#:115330 lot#:422790.Comprehensive reverse central screw catalog#: 115396 lot#:424640.Comprehensive locking screw, catalog#: 180500, lot#: 770390.Comprehensive locking screw, catalog#: 180502, lot#: 568050.Comprehensive locking screw, catalog#: 180503, lot#: 770430.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.Review of the complaint history determined that no further action(s) is/are required.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: COMPREHENSIVE SHOULDER SYSTEM PRIMARY STANDARD LENGTH SHOULDER STEM
• 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: 6491318
• MDR Text Key: 72778120
• Report Number: 0001825034-2017-02555
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/29/2012
• Device Model Number: N/A
• Device Catalogue Number: 113652
• Device Lot Number: 496560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2012
• 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): Other