MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL PRIMARY HIP PROSTHESIS FEMORAL STEM CEMENTLESS; 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 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Medical products: p/n 00786401320, l/n unknown, femoral stem press-fit collarless.

Event Description

It was reported that the etching on the implant was different from the label on the box.The implant was labeled as extended, and the box was labeled as standard.There was no impact to patient or delay reported.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This report is being submitted to relay additional information.The following sections have been updated:.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that the comingled - implant in the box was different from labeling on the folding carton dhr was reviewed and no discrepancies were found relevant to the reported event.Investigation results concluded the root cause for the reported issue can be manufacturing deficiency.

• Brand Name: TRABECULAR METAL PRIMARY HIP PROSTHESIS FEMORAL STEM CEMENTLESS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6881904
• MDR Text Key: 88002813
• Report Number: 0001822565-2017-06530
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2018

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 Model Number: N/A
• Device Catalogue Number: 00786401300
• Device Lot Number: 63703649
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 01/18/2018; 06/07/2018
• Supplement Dates FDA Received: 01/19/2018; 07/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0939-2018
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 99