MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOMXL +3 MM HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown glenoid, unknown stem, unknown taper adapter.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-6812, 0001825034-2017-06814, 0001825034-2017-06815.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

It is reported that patient has been indicated for a left total shoulder revision procedure due to an unknown reason.Attempts have been made and additional information on the reported event is not available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: pn 115378 ln 453620 humeral tray ; pn 118000 ln 590380 taper adapter; pn 115326 ln 238230 glenosphere ; pn 113665 ln 503390 stem ; pn 110027734 ln 716060 vrs baseplate.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause could not 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

It is reported that patient has been indicated for a left total shoulder revision procedure due to dislocation.Attempts have been made and additional information on the reported event is not available at this time.

• Brand Name: ARCOMXL +3 MM HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): .; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6828064
• MDR Text Key: 83905858
• Report Number: 0001825034-2017-06813
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-115367
• Device Lot Number: 145660
• Other Device ID Number: (01) 00880304 47682 3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2017
• 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): Other