MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM STD FACE LINER SZ 25; PROSTHESIS, HIP

Catalog Number 11-107324

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Ossification (1428); Failure of Implant (1924); Scar Tissue (2060); Ambulation Difficulties (2544)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported a patient underwent a right hip procedure approximately 4 years post implantation due to an implant fracture and noise.The liner was removed and replaced.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported a patient underwent a right hip revision approximately four years post implantation due to a failure of the liner.The patient was also presenting with squeaking, clicking and instability.During the revision, the liner disassociated and fracture from the locking ring with the liner freely moveable within the shell.The head and liner were remove and replaced.At the end of the procedure, the surgeon noted that the patient continues to have limited range of motion due to excessive scar tissue within the joint.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; g3; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient recently noticed a clicking sensation with instability in the hip, x-rays revealed failure of the constrained liner of the right hip.The constrained liner had catastrophic poly failed with total detachment of the metal constraining ring and the majority of the polyethylene cup was freely movable within the acetabular shell.Extensive scar tissue encountered with no true muscle or soft tissue planes identifiable.Complaint confirmed based on evaluation of the provided medical records.A definitive root cause was unable to be established.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.

• Brand Name: FREEDOM STD FACE LINER SZ 25
• 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: 17885150
• MDR Text Key: 325073875
• Report Number: 0001822565-2023-02747
• Device Sequence Number: 1
• Product Code: KWZ
• UDI-Device Identifier: 0088030420347
• UDI-Public: (01)0088030420347(17)220814(10)311590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2022
• Device Catalogue Number: 11-107324
• Device Lot Number: 311590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2017
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female