MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 54 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Off-Label Use (1494); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: microport cat#pha04444 delta option head lot#1765758, microport cat#pha044md delta option neck sleve lot#1804123, microport cat#pprcls05 profemur preserve classic stem lot#1801102.Foreign source: canada.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent hip surgery.Subsequently, patient was revised approximately 1 (one) year later due to the acetabulum separating (ceramic from metal).Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.Therefore, 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.

Event Description

No further event information available at the time of this report.

• Brand Name: LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 54 MM O.D.
• 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: 15370409
• MDR Text Key: 299377395
• Report Number: 0001822565-2022-02558
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024359505
• UDI-Public: (01)00889024359505(17)290630(10)64307098
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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 Model Number: N/A
• Device Catalogue Number: 00151505444
• Device Lot Number: 64307098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• 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 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male