MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 2/14 NECK TAPER STANDARD BODY EXTENDED NECK; PROSTHESIS, HIP

Catalog Number 00786401420

Device Problem Unstable (1667)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat #: 110010267/ g7 osseoti multihole 52mm e/lot #: 65401388.Cat #: 00625006530 / bone screw self-tapping 6.5 mm dia.35 mm length/ lot #: j7303650.Cat #: 00625006535 / bone screw self-tapping 6.5 mm dia.40 mm length / lot #: j7307828.Cat #: 20123607 / g7 liner, longevity, high wall / lot #: 6465338008.Cat #: 00877503602 / biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14 / lot #: 3103630.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.

Event Description

It was reported that a patient started to experience pain, difficulty ambulating, and had a bone fracture approximately nine weeks post implantation.A revision procedure has not been scheduled to date.Attempts have been made and no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Device was used for treatment.The reported product was reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed on sep 7, 2022.The surgeon noted no complications, however indicated morbid obesity added complexity to the surgical approach and placement.Following the surgery, the patient began experiencing pain, instability, and difficulty walking after physical therapy.A calcar fracture and stem subsidence was identified.Surgical intervention has not taken place yet.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.As no surgical or medical intervention has taken place or is scheduled to take place, this case is considered to be not reportable.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

There is no update to the original complaint description provided.

• Brand Name: FEMORAL STEM 2/14 NECK TAPER STANDARD BODY EXTENDED NECK
• 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: 15872075
• MDR Text Key: 304416940
• Report Number: 0001822565-2022-03287
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051491
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00786401420
• Device Lot Number: 65515966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Disability
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 129 KG