MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 50MM O.D. SIZE HH POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH HH LINERS; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  malfunction  

Event Description

It was reported the liner would not fully seat with the cup.The patient's bone quality was too poor; therefore, the surgery was completed with bipolar devices.There was no consequences or impact to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical products: cat# 11-165236 lot 497960 ringloc bi-polar zimmer cat# 192412 lot 000260 echo por fmrl.Cat # 00625006520 lot j7360863 bone scr.Cat # 00625006520 lot j7373554 bone scr.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03589.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified liner was returned partially seated in the shell.Deformation damage was noted around the middle of the three cluster holes of the shell, along with nicks and scratches.The deformation extends into the machined locking groove.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.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: 50MM O.D. SIZE HH POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH HH LINERS
• 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: 16067920
• MDR Text Key: 307295398
• Report Number: 0001822565-2022-03566
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024151345
• UDI-Public: (01)00889024151345(17)320809(10)65540798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200823
• 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,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00875705001
• Device Lot Number: 65540798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• 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 Age: 71 YR
• Patient Sex: Female