MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IMPACT HI-WALL LNR 28MM SIZE 4 PROSTHETIC, HIP

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Pain (1994)

Event Date 08/20/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: item # 163132 item name 28mm mod hd ceramic std nk lot #163132. Item # 103531 item name ti low profile screw 6. 5x20mm lot #083740. Item # 103530 item name ti low profile screw 6. 5x15mm lot #442770. The device will not be returned for analysis as product location is unknown; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04445.

Event Description

It was reported the patient underwent a right tha on an unknown date approximately 13 years later the patient was revised due to wear likely secondary to vertical position of the cup. The patient had a recent accident at work and went to see his physician with mild buttock and thigh pain. It was also noted the patient had an osteolytic cyst during the procedure which was removed. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: IMPACT HI-WALL LNR 28MM SIZE 4
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11109259
• MDR Text Key: 224811531
• Report Number: 0001825034-2020-04446
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/1997
• Device Model Number: N/A
• Device Catalogue Number: 112024
• Device Lot Number: 532880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/1992
• 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 Treatment Data

Date Received: 01/04/2021 Patient Sequence Number: 1