MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSYS FEMORAL STEM; 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 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00784101550 ¿ versys femoral stem ¿ 63083654.Report source (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 06871.

Event Description

It was reported that during a hip procedure, a femoral stem was implanted and was too large.The stem was then removed and noted to be a larger size than what was noted on the label.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product and package confirmed that product label did not match the etchings on the product inside.Review of the dhr found that the label specification sheet is for part 00784101550 and the sample label shows lot 63083654r part 00784101550, which is incorrect for order 62766813r.Investigation results concluded that the reported event was due to a manufacturing deficiency.A corrective action has been initiated to address this 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.

Event Description

No additional event information to report at this time.

• Brand Name: VERSYS FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8152876
• MDR Text Key: 130050454
• Report Number: 0001822565-2018-06872
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K922071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

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: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00784101820
• Device Lot Number: 62766813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 07/29/2019
• Supplement Dates FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 91