MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROTHESIS, HIPS

Model Number N/A

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Osteolysis (2377); Osteopenia/ Osteoporosis (2651)

Event Date 11/17/2023

Event Type  Injury  

Event Description

It was reported the patient had an initial left total hip arthroplasty.The patient had an implant fail and break.Subsequently, the patient was revised, and the implant was replaced.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent an initial left total hip arthroplasty on unknown date with competitor product.The patient underwent their first revision due to trochanter fracture with zb components implanted.The patient underwent a second revision nineteen (19) years post implantation due to pain, ambulation difficulties, fractured implant, and instability.During the revision, it was confirmed implant fracture of stem, loosening, scar tissue, implant wear, and upon reduction of trial components felt a crack along the proximal medial aspect of the femur.All components were exchanged with stryker cup, liner, stem, delta biolox head, and unknown cerclage wires with some difficulty reducing final components.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.D1: revision femoral stem beaded fullcoat plus 12/14 neck taper - standard body size 13 13 mm distal stem diameter 200 mm stem length.D10: 00631006440 xlpe 10deg poly liner 64 x 40 75213100.00-6200-064-20 trilogy fm acet shl 64 od univ 25632500.00625006550 bone screw self-tapping 6.5 mm dia.50 mm length 22058300.00625006530 bone screw self-tapping 6.5 mm dia.30 mm length 80097864.00625006540 bone screw self-tapping 6.5 mm dia.40 mm length 23891800.00801804003 femoral head sterile product do not resterilize 12/14 taper 53226000.00223200205 integral long gtr w/4 cables 77108200.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04) - stem.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 related to the reported event.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 an unknown day with competitor product.The first revision occurred due to a bone fracture, zb products were placed.Osteolysis was reported around the femur and the stem was identified to be fractured and loose.During the revision instability and pain were noted, as well as wear to the polyethylene.All products were removed, and competitor products were placed.The bone fracture occurred during trialing with competitor products.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total hip arthroplasty with a fractured femoral stem, fractured proximal cerclage wire and possible loose component within the superior aspect of the joint space.A definitive root cause cannot be determined.This complaint was confirmed based on the provided x-rays and medical records confirming the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: UNKNOWN STEM
• Type of Device: PROTHESIS, HIPS
• 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: 18817874
• MDR Text Key: 336677710
• Report Number: 0001822565-2024-00717
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: HIP-OTHER-STEMS-UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/17/2024; 05/07/2024
• Supplement Dates FDA Received: 05/06/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2003
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Race: White