MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOM XL 44-36 STD HMRL BRNG; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Medical product - unknown humeral bearing, cat#: ni lot#: ni; unknown humeral tray, cat#: ni lot#: ni.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

During a shoulder arthroplasty, the humeral bearing would not seat into the humeral tray.Another humeral bearing was used to complete the procedure.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Concomitant medical products: medical product - comp rvs tray co 44mm, cat#: 115370 lot#: 209790; arcom xl 44-36 std hmrl brng, cat#: xl-115363 lot#: 253430.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Product was visually examined.The polyethylene bearing has circular abrasions indicating impaction.The lip where the locking ring locks into place is damaged.The slot also has damage noted.A dimensional review is not possible due to the damage to the poly.The complaint is considered to be confirmed due to the damage to the poly which would have prevented it from seating.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.This issue was previously addressed by preventative action where a training video was distributed to the field, an optional bearing assembly tool was created, and surgical technique was updated.Root cause was unable to 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.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• 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: 6437485
• MDR Text Key: 70987306
• Report Number: 0001825034-2017-02126
• 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,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/22/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 488870
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2016
• 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 Age: 79 YR