MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NK TPR SZ 6 EXTENDED OFFSET; PROSTHESIS, HIP

Catalog Number 00771100640

Device Problems Inadequacy of Device Shape and/or Size (1583); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

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.

Event Description

It was reported that during the procedure, the stem subsided when inserting it into the femur.Another box of the same size stem was opened and used to "complete" the procedure.It was noted that the first stem was visibly smaller than the second.There was no harm or health consequences to the patient.Attempts have been made and no further information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04)-stem; reported event was confirmed by review of the product.Visual examination of the returned product identified scratches are seen near the conical taper.The device is etched as item number 7711-06-40 / lot number 65236202.The stem was confirmed to be a size 4 using overlay 25-2009-695-04-d.No packaging materials were returned.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing deficiency, as the returned stem matches the size of a size 4 stem, but was etched to be a size 6.A corrective action was opened as a result of the investigation.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: FEMORAL STEM 12/14 NK TPR SZ 6 EXTENDED OFFSET
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17325074
• MDR Text Key: 319044536
• Report Number: 0001822565-2023-01907
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024131699
• UDI-Public: (01)00889024131699(17)311002(10)65215129
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00771100640
• Device Lot Number: 65236202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female