MAUDE Adverse Event Report: ZIMMER GMBH ARTEK CUP ME 38/46; N/A

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Reaction (2414)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item# 19.38.04, lot# b541430, metasul-femoral head 38 xs; item# 91.36.38-46, lot# 2052390, artek cup me 38/46.Premarket identification: 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.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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).Devices in transit to manufacture.

Event Description

It was reported that the patient underwent revision surgery approximately 17 years post implantation due to elevated metal ion.Attempts to obtain additional information have been made; however no more has been provided at this time.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend has been identified.Event description: it was reported that the patient had hip implant surgery on (b)(6) 2001 due to arthrosis.After tests elevated ion levels, cobalt and chromium, were detected therefore the patient underwent to a revision surgery on (b)(6) 2019.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received due to internal procedure dealing with products involved in an incident.Device analysis: no product was returned to zimmer biomet for in-depth analysis due to internal procedure dealing with products involved in an incident.Review of product documentation: all involved devices are intended for treatment.The product combination was approved by zimmer biomet as per surgical technique.Conclusion: it was reported that the patient had hip implant surgery on (b)(6) 2001 due to arthrosis.After tests elevated ion levels, cobalt and chromium, were detected, therefore the patient underwent to a revision surgery after approx.18 years in-vivo on (b)(6) 2019.Neither medical documents nor the devices have been received due to internal procedure of the hospital.Therefore, neither visual nor dimensional evaluation could be performed.Based on the surgical technique applicable at the time of implantation the head and the cup are compatible.However, the stem is unknown, therefore, the compatibility of the stem and the head could not be reviewed.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Therefore, the document-based investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the significant lack of information and the unavailability of the products, we were neither able to confirm the reported event nor to identify a root cause for the reported event.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: ARTEK CUP ME 38/46
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8669565
• MDR Text Key: 147018125
• Report Number: 0009613350-2019-00361
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2006
• Device Model Number: N/A
• Device Catalogue Number: 91.36.38-46
• Device Lot Number: 2052390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR