MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM COLLARED 12/14 NK TAPER STND NECK; PROSTHESIS, HIP

Catalog Number	00784101100
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a combination product.(b)(4).G2: (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.
Event or Problem Description
It was reported that during a procedure, the surgeon was not able to seat the prosthetic into the femur for proper implantation.There was no harm or impact to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem.Visual examination of the returned product identified gouges between the collar and taper and on the underside of the collar from attempted use.No other damage was noted.The complaint was confirmed based on the returned device.Dhr was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event was due to the surgeon not following the surgical technique to properly implant the stem.The alignment guide was not used to implant the stem which is necessary to use to achieve proper rotational alignment, otherwise it may result in femoral fracture or the stem not fully seating.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 or Problem Description
No additional event information to report at this time.

• Brand Name: FEMORAL STEM COLLARED 12/14 NK TAPER STND NECK
• Common Device Name: 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: 17162116
• Report Number: 0001822565-2023-01639
• Device Sequence Number: 12205479
• Product Code: LPH
• UDI-Device Identifier: 00889024136007
• UDI-Public: (01)00889024136007(17)290531(10)64266583
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 00784101100
• Device Lot Number: 64266583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown