MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALPHA INSERT, PE, HOODED, II/28 HIP PROSTHESIS

Model Number N/A

Device Problems Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states. Concomitant medical products: fitmore, shell with screw cones, uncemented, 52/ii; catalog#: 01. 00024. 552; lot#: 2365795. Therapy date: (b)(6) 2021. The manufacturer received x-rays and other source documents for review. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. (b)(4).

Event Description

Patient was implanted on the left side and underwent a revision surgery due to osteolysis from polyethylene wear. Tm modular cup and liner were implanted during the revision surgery.

• Brand Name: ALPHA INSERT, PE, HOODED, II/28
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11588585
• MDR Text Key: 242916591
• Report Number: 0009613350-2021-00152
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 01.00010.309
• Device Lot Number: 2367018
• 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: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2007
• 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: 03/30/2021 Patient Sequence Number: 1