MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 58MM CUP SIZE REVISION SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat# p0463046 lot# 0001611795 avan cmntd shell ss 46mm.Cat# ep-200146 lot# 694590 act artic e1 hip brg 28x40mm.Cat# 87-5954 lot# 9269605 s-rom femoral head.G2: foreign: australia multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2023 - 00178 0002648920 - 2023 - 00179 0001822565 - 2023 - 02058 0001822565 - 2023 - 02059 0002648920 - 2023 - 00174 0001822565 - 2023 - 02060.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial hip procedure.Subsequently, the patient underwent a revision approximately 1 year later due to bone loss.Attempts have been made and no further information has been provided.

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.Medical records were not provided.A definitive root cause cannot be determined.It was identified some of the screws used are not compatible with the shell, however it is unknown if it caused or contributed to the reported event.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 information at the time of this report.

• Brand Name: 58MM CUP SIZE REVISION SHELL
• 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: 17471389
• MDR Text Key: 320516654
• Report Number: 0001822565-2023-02061
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024310889
• UDI-Public: (01)00889024310889(17)250929(10)64803364
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K001759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00700005820
• Device Lot Number: 64803364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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 Sex: Female
• Patient Weight: 80 KG