MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Swelling (2091)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(udi #): (b)(4).Concomitant medical product: comprehensive shoulder system primary shoulder stem, catalog#: 113653, lot#: 046730.Ringloc + replacement ring, catalog#: 106021, lot#: 217060.Comprehensive reverse shoulder humeral tray with locking ring, catalog#: 115375, lot#: 960730.Comprehensive instrumentation humeral tray taper extraction pliers - replacement tips, catalog#: 110028522, lot#: 494350.No device or photos were received for evaluation; therefore the condition of the device is unknown.Device history records (dhr) was reviewed which showed no deviations or anomalies relevant to the reported event.Review of the complaint history determined that no further action(s) is/are required as no trends were identified.A definite root cause cannot be determined with the information provided.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-04658-2, 04343, and 04345.

Event Description

Patient underwent a shoulder revision procedure, and four months post-implantation has had blood and fluid drained at the incision site three separate times.Patient underwent a further procedure approximately seven months post-implantation due to hemarthrosis.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING
• 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: 6732752
• MDR Text Key: 80697441
• Report Number: 0001825034-2017-04348
• 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: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/19/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-115367
• Device Lot Number: 625780
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• 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: 76 YR