MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH EXTRACTION INSTRUMENT, STRAIGHT; HIP INSTRUMENT

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2021

Event Type  malfunction  

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.Medical products: jaws for 01.00529.102, plastic; catalog#: 01.00529.103; lot#: unknown.The manufacturer received 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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

During a surgery while extraction of an uncemented stem from the femoral canal using a femoral extraction tool the plastic liner broke.No plastic debris broke off and no damages done.The instrument was used 20 to 30 times.Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.

Event Description

During the investigation of this event, the device reported on this medwatch was determined to be an associated device therefore included in medwatch 0009613350-2021-00516-1 as a concomitant device.Please delete the present medwatch 0009613350-2021-00519 from your records.

Manufacturer Narrative

During the investigation of this event, the device reported in this medwatch was determined to be an associated device therefore included in medwatch 0009613350-2021-00516-1 as a concomitant device, where investigation results have been submitted.Please delete this medwatch 0009613350-2021-00519 from your records.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: EXTRACTION INSTRUMENT, STRAIGHT
• Type of Device: HIP INSTRUMENT
• 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: 12589447
• MDR Text Key: 276579409
• Report Number: 0009613350-2021-00519
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

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: 0100529102 (VOID)
• Device Lot Number: 4501960477 (VOID)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization