MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 113654, comp primary stem 14mm std, lot # 629590; catalog #: 115330, comp rvrs shdr glen bsplt+ha, lot # 094170; catalog #: 115381, comp rvs cntrl scr 6.5x25mm st, lot # 892000; catalog #: 118001, versa-dial/comp ti std taper, lot # 152020; catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 71794257; catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 704710; catalog #: 180503, comp locking screw 4.75x30mm, lot # 324680; catalog #: 180505, comp locking screw 4.75x40mm, lot # 805240; catalog #: 405889, comp rvs 2.7mm dia drl, lot # 313090; catalog #: 405883, comp rvs 3.2mm drl, lot # 049280; catalog #: 405800, comp rev shldr 9 in steinmann, lot # 520640; catalog #: 32-486265, 1/8 quick rel drl sterile 2pk, lot # 963270; catalog #: 110004347, sig glen ct gd/bone model set, lot # 902510.Customer has not indicated whether or not the product will be returned to zimmer biomet for investigation.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: 0001825034-2017-02836, 02833, 02890, 02885.

Event Description

It was reported that the patient underwent a left total reverse shoulder arthroplasty revision approximately eighteen months post-implantation due to instability and recurrent dislocations.The glenosphere, humeral tray, and humeral bearing were removed and replaced.No additional patient consequences have been reported.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional information.The reported event was not able to be confirmed.No product was received for evaluation.The initial operation notes identified no issues and stated that the implant was stable.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.The reported implants were reviewed for compatibility with no issues noted.A definite root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 REVERSE SHOULDER GLENOSPHERE 36MM
• 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: 6525571
• MDR Text Key: 73812640
• Report Number: 0001825034-2017-02833
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 115313
• Device Lot Number: 318690
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 11/06/2017
• Supplement Dates FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2013
• 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: 68 YR