MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown stem, catalog number:00633405028 lot number:64165806 brand name:acetabular liner, unknown cup.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04651, 0001822565-2019-04650.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a revision procedure due to reduced mobility and a mri scan suggesting some localized tissue abnormalities around the hip prosthesis.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

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).

Event Description

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).

• Brand Name: UNKNOWN HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9255661
• MDR Text Key: 164433282
• Report Number: 0001822565-2019-04652
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024126084
• UDI-Public: (01)00889024126084
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE