MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE HUMERAL POLY LINER PLUS; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problem Urinary Retention (2119)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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: 0001822565 - 2019 - 01793, 0001822565 - 2019 - 01794, 0001822565 - 2019 - 01795.Not returned to manufacturer.

Event Description

It has been reported that patient underwent shoulder arthroplasty.Post surgery, patient was unable to void; therefore, straight catherization was performed two times to empty the bladder.No additional patient consequences were reported and the event was resolved on second day post surgery.

Manufacturer Narrative

Corrected: d7- product was not ex planted at the time of event.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.Medical records were reviewed and identified that no intraoperative complications found during initial procedure.A definitive root cause cannot be determined.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

No further event information is available at the time of this report.

• Brand Name: TM REVERSE HUMERAL POLY LINER PLUS
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8569749
• MDR Text Key: 143713674
• Report Number: 0001822565-2019-01792
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 00434903606
• Device Lot Number: 63500072
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00434901213, STEM, 62952503; 00434903611, GLENOSPHERE, 63466856; UNKNOWN BASEPLATE; 00434901213, STEM, 62952503; 00434903611, GLENOSPHERE, 63466856; UNKNOWN BASEPLATE
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 73