MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL RASP FOR HUMERAL STEM 9; ANA0TOMICAL SHOULDER TM COMBINED SYSTEM

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 01/29/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that the surgeon used the anatomical rasp for humeral stem 9 on (b)(6) 2016.The following statement was reported: "the cone of the domelock dome centric (expansion ball) seized on a rasp size 9.It was presumed that the rasp had a defect, so another rasp with the same size was used.The cone of the dome centric (expansion ball) was again a little bit seized.There are mechanical marks visible on the cone due to the defect.Therefore the surgeon discarded two domelock dome centric (expansion balls) and used the third dome centric (expansion ball) (lot 2817214) which was the one with less damage on the cone." the surgery was extended for 30 minutes.The implantation and explantation dates are left empty as the device involved in this complaint is an instrument.

Manufacturer Narrative

Dhr review results: dhr records were reviewed and found to be conforming.Trend analysis: a trend for the anatomical shoulder domelock dome (ref# 01.04227.005) has been identified.A recall for the anatomical shoulder domelock dome (ref# 01.04227.005) was initiated, report number: 9613350-05-11-2016-001-r.Event summary: the cone of the domelock dome centric (expansion ball) seized on a rasp size 9.It was presumed that the rasp was defect, so another rasp with the same size was used.The cone of the dome centric (expansion ball) was again a little bit seized.There are mechanical marks visible on the cone due to the defect.Therefore the surgeon discarded two domelock dome centric (expansion balls) and used the third dome centric (expansion ball) (lot 2817214) which was the one with less damage on the cone.Review of received data: three pictures are available.On two pictures the wear/mechanical marks on the cone of the domelock dome expansion balls is visible.Devices analysis: visual examination: the 2 domelock dome were returned assembled for investigation.The expansion balls show clear signs of wear perpedicular to the short axis of the elliptical cone, i.E.About 2 millimeters below the final part of the cone.The rest of the surface does not show signs of usage.The returned rasp is intact and does not show any usage damage.Conclusion summary: a mismatching in terms of design has been identified.A recall for the anatomical shoulder domelock dome (ref# 01.04227.005) has been initiated.Meassures have been initiated to eliminate the root cause.Zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: ANATOMICAL RASP FOR HUMERAL STEM 9
• Type of Device: ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5453887
• MDR Text Key: 38782504
• Report Number: 9613350-2016-00241
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• 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: 01.04233.090
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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