MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COMPREHENSIVE REVERSE BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Pain (1994)

Event Date 02/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reference: joseph n.Liu, grant h.Garcia, gregory mahony, hao-hua wu, david m.Dines, russell f.Warren, lawrence v.Gulotta (2016) sports after shoulder arthroplasty: a comparative analysis of hemiarthroplasty and reverse total shoulder replacement.Journal of shoulder and elbow surgery board of trustees.Volume 25, issue 6, pages 92 ¿926.Http://dx.Doi.Org/10.1016/j.Jse.2015.11.003 medical products: for the reverse arthroplasty: unknown stem, humeral tray, unknown glenosphere, unknown baseplate.Multiple mdr reports were filed for this event, please see associated reports: for the reverse arthroplasty: unknown stem for reverse arthroplasty 0001825034 - 2017 - 07316.Unknown humeral tray 0001825034 - 2017 - 07318.Unknown glenosphere 0001825034 - 2017 - 05603 - 1.Unknown baseplate 0001825034 - 2017 - 05604 - 1.It is unknown if 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.

Event Description

Information was received based on review of a journal article titled 'sports after shoulder arthroplasty: a comparative analysis of hemiarthroplasty and reverse total shoulder replacement' which is a retrospective review of consecutive rsta and hha patients collected from institution's shoulder arthroplasty registry.All patients playing sports preoperatively with minimum one year follow-up were included.This study is to determine if patients who are not candidates for anatomic tsa due to rotator cuff dysfunction, rheumatoid arthritis, or proximal humeral fracture had better return to sports when they underwent hha compared with rtsa.The study reported 43 patients complained of chronic pain postoperative (32 hha group and 11 rtsa group).

Manufacturer Narrative

Medical product: unknown comprehensive taper, catalog#: ni, lot#: ni unknown comprehensive reverse stem, catalog#: ni, lot#: ni unknown comprehensive reverse glenoid baseplate, catalog#: ni, lot#: ni unknown comprehensive reverse humeral tray, catalog#: ni, lot#: ni unknown comprehensive reverse glenosphere, catalog#: ni, lot#: ni.Reported event was unable to be confirmed due to limited information received from the customer.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 was unable to be performed, as the part number and lot number are unknown.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.

Event Description

Information was received based on review of a journal article titled 'sports after shoulder arthroplasty: a comparative analysis of hemiarthroplasty and reverse total shoulder replacement' which is a retrospective review of consecutive rsta and hha patients collected from institution's shoulder arthroplasty registry.All patients playing sports preoperatively with minimum one year follow-up were included.This study is to determine if patients who are not candidates for anatomic tsa due to rotator cuff dysfunction, rheumatoid arthritis, or proximal humeral fracture had better return to sports when they underwent hha compared with rtsa.The study reported 11 patient deaths (4 rtsa group and 7 hha group).

• Brand Name: UNKNOWN COMPREHENSIVE REVERSE BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6888136
• MDR Text Key: 87194029
• Report Number: 0001825034-2017-07319
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 09/28/2017
• Supplement Dates FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death; Hospitalization; Required Intervention