MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 2, TAPER 12/14; AVENIR MULLER STEM

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products and therapy date detail of product: -item # 0106010001, item name avenir muller, stem, standard, uncemented, ha, 1, taper 12/14, lot / # 2956599.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that during a surgery the engraving on the cone showed a different size from the one shown on the package.The wrong size shaft was in the packaging.

Event Description

No event update.

Manufacturer Narrative

Investigation results were made available.Dhr review: ref:01.06010.001 ; lot: 2955599.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.There is neither a dhr nor an expiration date for sterility for ref.01.06010.002 lot.2956599 available, as this lot hasn't been released yet.Trend analysis: no trend considering the following event is identified: product mix-up/wrong labeled product.Review of event description: it was reported that during a surgery an avenir stem size 1 should be implanted.The packaging and diverse labeling were correct.Upon inserting the shaft it was noticed that the engraving on the cone showed size 2 and not size 1.The wrong size shaft was in the packaging.Packaging labels show: ref.01.06010.001 lot 2955599.Shaft engraving shows ref.01.06010.002 lot 2956599.Review of received data: - the received pictures confirm that the labels on the packaging do not correspond to the description on the stem.Devices analysis: comparing the label identification to the description of the laser marking on the stem confirms that the labeling is not correct, resp.The labels do not correspond to each other.All labels on the outer box and the bag show: ref.01.06010.001 lot 2955599.On the cone of the stem following identification is laser marked: ref.01.06010.002 lot 2956599.Thus the item number and also the lot number do not match.Review of product documentation: in the warehouse 5 pieces of the product item# 01.06010.001, lot# 2955599 were inspected.All 5 stems were wrongly labeled with "01.06010.002" and "2956599".The labeled item - lot combination also exists in the database (manufacturing date 13.07.2018), but has never been released (status from 18-oct-2018).Conclusion summary it was reported that during a surgery an avenir stem size 1 should be implanted.The packaging and diverse labeling were correct.Upon inserting the shaft it was noticed that the engraving on the cone showed size 2 and not size 1.The wrong size shaft was in the packaging.Packaging labels show: ref.01.06010.001 lot 2955599.Shaft engraving shows ref.01.06010.002 lot 2956599.Checking the returned product showed following result: comparing the label identification to the description of the laser marking on the stem confirms that the labeling is not correct, resp.The labels do not correspond to each other.All labels on the outer box and the bag show: ref.01.06010.001 lot 2955599.On the cone of the stem following identification is laser marked: ref.01.06010.002 lot 2956599.Thus the item number and also the lot number do not match.To check if potentially the whole lot is affected, the warehouse opened and inspected 5 pieces of the product item# 01.06010.001, lot# 2955599.All 5 stems were wrongly labeled with "01.06010.002" and "2956599".Based on the results of the complaint investigation it can be concluded that while manufacturing the avenir stems a commingle occurred.Based on the available information further investigation has been initiated to determine the necessity of potential corrective and/or preventive actions.A recall has been conducted (affected clinics in germany and switzerland, usa not affected).Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 2, TAPER 12/14
• Type of Device: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8045212
• MDR Text Key: 128258751
• Report Number: 0009613350-2018-01131
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024479470
• UDI-Public: 00889024479470
• Combination Product (y/n): N
• PMA/PMN Number: K123392
• 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: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.002
• Device Lot Number: 2956599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1