MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN CLS RASP

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive the device for investigation.No surgical report or x-rays were provided for review.As no lot numbers was provided for the instrument, the instrument history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that an implantation surgery was planned with a cls spotorno stem.It was reported that after rasping the cls broacher, the final implant got sinked.The doctor was complaining that the rasp (catalogue number unknown) and the final implant were missmatching.The surgery was completed without delay with a wagner stem.

Manufacturer Narrative

This case will be invalidated since it is a duplicate of (b)(4) (mfr report number: 0009613350-2016-01037).Therefore, zimmer (b)(4) will consider this case as closed.Zimmer's reference number is (b)(4).

Event Description

Follow up information received on november 08, 2016.This case is a duplicate of (b)(4) (mfr report number: 0009613350-2016-01037).Therefore, this case will be invalidated.Please rectify your records.

• Brand Name: UNKNOWN CLS RASP
• Type of Device: UNKNOWN CLS RASP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5871531
• MDR Text Key: 52995606
• Report Number: 0009613350-2016-01117
• Device Sequence Number: 1
• Product Code: HTR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PN/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: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other