MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ACROM XL 44-41 STD +3 HMRL BRG; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cyst(s) (1800)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Therapy date - (b)(6) 2017.Concomitant medical products - comp rvs tray +5 mm co 44 mm, catalog # 115375, lot # 960730.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr repots were filled for this event: 0001825034 - 2017 - 06947.

Event Description

It was reported that patient underwent the removal of an anterior ganglion cyst in the operative left shoulder.No implants were removed.Operative notes stated the patient has experienced recurrent effusion.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Concomitant medical product: comprehensive reverse shoulder humeral tray w/ locking ring, catalog#: 115375, lot#: 960730.Ringloc + replacement ring, catalog#: 106021, lot#: 217060.Comprehensive shoulder system primary stem, catalog#: 113653, lot#: 046730.Reported event was confirmed by review of operative notes.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.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.

• Brand Name: ACROM XL 44-41 STD +3 HMRL BRG
• 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: 6841319
• MDR Text Key: 84628262
• Report Number: 0001825034-2017-06948
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 11/09/2017
• 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