MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DUAL MOBILITY BEARING ARCOM XL 28MM HEAD SIZE 46MM BEARING SIZE G; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

Udi# (b)(4).Corrective action has been initiated to address the reported issue.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-04293 / 04294).

Event Description

During an open reduction internal fixation procedure for a fractured acetabulum it was noticed that a hi-wall liner was packaged as a dual mobility bearing.Another bearing was available and used to complete the procedure without delay.

Manufacturer Narrative

(b)(4).This follow up report is being filed to relay corrected and additional information.Review of device history records found these units were released to distributor with no deviations or anomalies.Visual examination of the returned product confirmed the complaint as the box and product did not match.Complaint history review identified an issue which was addressed.The root cause is likely that the lots were mixed when they were prepped for the sterilization operation.Corrective action has been initiated to address reported issue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DUAL MOBILITY BEARING ARCOM XL 28MM HEAD SIZE 46MM BEARING SIZE G
• Type of Device: PROSTHESIS, HIP
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6061121
• MDR Text Key: 58527466
• Report Number: 0001825034-2016-04293
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110555
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/13/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-200152
• Device Lot Number: 339260
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• 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: 77 YR
• Patient Weight: 32