MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE GLENOSPHERE 36MM +3MM OFFSET; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problem Urinary Tract Infection (2120)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: 115370 comp rvs tray co 44mm 652170; 115330 comp rvrs shdr glen bsplt +ha 786790; 118001 versa-dial/comp ti std taper 352400; xl-115363 arcom xl 44-36 std hmrl brng 285250; 113636 comp primary stem 16mm mini 614090; 115396 comp rvs cntrl 6.5x30mm st/rst 331330; 180554 comp lk scr 3.5hex 4.75x35 st 602980; 180550 comp lk scr 3.5hex 4.75x15 st 410190; 180550 comp lk scr 3.5hex 4.75x15 st 610760.The investigation is in progress.A follow up report will be submitted once the investigation is completed.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08639.

Event Description

It was reported that the patient had difficulty in urinating after closed reduction of a reverse total shoulder prosthesis was performed.Patient ¿had a lot of visits to the er¿ for in and out catheters, and subsequently developed a uti.Patient was referred to a urologist and prescribed medication for treatment.No additional information is available.

Manufacturer Narrative

The follow up report is being submitted to relay additional information received.The complaint is confirmed based on the follow up visit notes that was provided.Review of device history records found these units were released to distribution with no related deviations or anomalies.A root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE REVERSE GLENOSPHERE 36MM +3MM OFFSET
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7837455
• MDR Text Key: 118914187
• Report Number: 0001825034-2018-08640
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115313
• Device Lot Number: 142560
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/05/2018
• 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: 85 YR
• Patient Weight: 79