MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK SCREW; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Catalog Number UNK SCREW

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

Patient Problems Scar Tissue (2060); Unequal Limb Length (4534)

Event Date 02/24/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial left total hip arthroplasty on unknown date.Subsequently, the patient was revised approximately eleven (11) months ago due to loosening of the acetabular component and received a pmi device at that time.During the revision, a limb length discrepancy and scar tissue were also noted, as well as a fractured screw that was removed.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00266.D10: item# unk acetabular component; lot# unk.Item# unk femoral head; lot# unk.Item# unk stem; lot# unk.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient is status post left total hip replacement with loosening of the acetabular cup, therefore the present procedure was indicated.Leg length was approximately 2cm short on the left compared with that of the right, scar tissue was removed from about the proximal femur.A fractured screw remained and this was removed with the needle driver.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.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: UNK SCREW
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19116719
• MDR Text Key: 340339432
• Report Number: 0001825034-2024-00267
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 95 YR
• Patient Sex: Male