MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET HIP SYSTEM MODULAR HEAD COMPONENT STANDARD NECK; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

It was reported when the final head in a hip arthroplasty was opened, it contained the wrong size as labeled.It was a 36 minus 3 head not a 32 plus 0 head as labeled.A new, correct implant was opened and used without any patient consequences.

Manufacturer Narrative

(b)(4).Concomitant medical products: 36mm cocr mod hd -3mm pn11-363661 ln299340.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product and packaging confirmed that the product and packaging do not match as reported.Search in xa to identify the lot number product determined that the product is part 11-363661.Dimensional analysis of the returned product confirmed that it is consistent with part 11-363667.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.The root cause of the reported event is attributed to manufacturing deficiency.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: BIOMET HIP SYSTEM MODULAR HEAD COMPONENT STANDARD NECK
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6735383
• MDR Text Key: 80769777
• Report Number: 0001825034-2017-05048
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK082446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 163669
• Device Lot Number: 276760
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• 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