MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 58 MM O.D.; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Anemia (1706); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 02180, 0001822565 - 2023 - 02181, 0001822565 - 2023 - 02182.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 a right hip arthroplasty.Subsequently, patient is allegedly experiencing pain, difficulty walking, losing blood and is severely anemic.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).This report will be reported under mfr 0002648920 - 2023 - 00288.

Event Description

No further information at the time of this report.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 58 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: 17595622
• MDR Text Key: 321643223
• Report Number: 0001822565-2023-02179
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

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: 00620005822
• Device Lot Number: 60255582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 113 KG