MAUDE Adverse Event Report: ZIMMER GMBH SULOX, HEAD, M, 32/0, TAPER 12/14; SULOX HEAD

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Code Available (3191)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The device was returned for investigation and the investigation has been initiated.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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

It was reported that surface damage of sulox, head, m, 32/0, taper 12/14.During surgery on (b)(6) 2017, surface damage was found on the ceramic head.The surgery was successfully completed with another device.Note: the implantation and explantation dates are left empty as the device involved in this complaint is damaged and the actual device was not implanted.Hence, no expiration date is captured, for the same reason.

Manufacturer Narrative

Additional information has been requested and is currently not available.No trend considering the following event is identified: scratches on the surface.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it was reported that during a surgery on (b)(6) 2017 the surface of a sulox head was found damaged.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis visual examination: the ceramic head has been received for an investigation.There are three metal transfer lines visible on the articulating surface of the head.One metal transfer line is longer than the others and is around 1cm long and dark.Additionally, there are metal transfer lines/areas visible along the taper area of the ceramic head.Root cause analysis root cause determination using dfmea: unable to assemble head on stem taper due to wrong sizing/ combination, particles, damaged taper => possible: no information provided about sizing of the stem and combination.Unsterile product due to improper handling during surgery due to wrong handling of device due to wrong information => possible: correct handling of the device is not under control of zimmer biomet.Conclusion summary: the product was received for investigation.The review of the dhr indicates that the head met all requirements to perform as intended.Moreover, the surface of the head is 100% visually inspected before it is released.No additional similar event has been report for this product lot number.Therefore a manufacturing issue seems very unlikely.The metallic transfer lines in the taper indicates that the biolox head has already assembled onto the stem taper.Therefore, it can be assumed that the marks on the articulation surface emerged from a handling error after it was taken out of the packaging.Handling of the component is outside of zimmer biomet control.However, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: SULOX, HEAD, M, 32/0, TAPER 12/14
• Type of Device: SULOX HEAD
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7103627
• MDR Text Key: 95382112
• Report Number: 0009613350-2017-01719
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• 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: 17.32.06
• Device Lot Number: 2915273
• Other Device ID Number: 00889024416987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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 Sequence Number: 1