MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOM XL 44-41 RTNV +3 HMRL BR; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problems Difficult to Insert (1316); Device Damaged by Another Device (2915)

Patient Problem No Code Available (3191)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not 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.Concomitant medical products: 115370, comp rvs tray co 44 mm, 187340.

Event Description

It was reported that the amount of impact needed to seat the poly onto the locking tray caused concern as the locking ring was damaged.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.The following sections were updated: report type - adverse event and product problem.Outcomes attributed to adverse event - required intervention to prevent permanent impairment/damage (devices).Date of this report - sep 13, 2017.Describe event or problem.Date received by manufacturer - sep 12, 2017.Type of report - follow-up.Type of reportable event - serious injury.If follow-up, what type - additional information.

Event Description

It was reported that the humeral tray was impacted onto the bone, removed, and then another tray was impacted and implanted because the locking ring on the humeral tray was not locking properly on the poly.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.As returned the bearing is attached to the tray and is well secured by the lock ring.Pieces exhibit proper alignment and have no signs of damage or wear.Device performed as intended.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 were trends identified.No failure detected, device operated within specifications.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 44-41 RTNV +3 HMRL BR
• Type of Device: PROSTHESIS, EXTREMITY
• 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: 6848309
• MDR Text Key: 85140912
• Report Number: 0001825034-2017-06986
• 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,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/30/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-115368
• Device Lot Number: 463040
• Other Device ID Number: (01)00880304475830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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): Required Intervention