MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS; 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 09/19/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.(b)(4).Investigation is ongoing and when additional information is received, a follow-up report will be submitted to the fda.This report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-04228 / 04229).

Event Description

During a hip arthroplasty it was noticed that an acetabular liner was packaged as a dual mobility bearing.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

During a hip arthroplasty it was noticed that an acetabular liner was packaged as a poly bearing.Another device was used to complete the procedure.There was a 40 minute delay as a result.

Manufacturer Narrative

This follow up report is being filed to relay corrected and additional information.Complaint sample was evaluated and the reported event was confirmed.Reported event has been confirmed.Visual examination of the returned product confirmed the complaint as the box and product did not match.Products were also requisitioned from inventory and it was confirmed that the products match the box.This indicates that only part of the lot was mixed.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was likely due to mixing of lots during sterilization operation.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: ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
• 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: 6045607
• MDR Text Key: 58018585
• Report Number: 0001825034-2016-04229
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• 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: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• 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-108323
• Device Lot Number: 761680
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• 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 Outcome(s): Other