MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER, HUMERAL HEAD, 52/23; ANATOMICAL PRESS-FIT HUMERAL STEM

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive 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.(b)(4).

Event Description

It was reported that during a surgery on (b)(6) 2017 the package of an anatomical shoulder, humeral head, 52/23 was not vacuum sealed well and had air in it.Another similar size was opened and that implant had been packaged properly.

Manufacturer Narrative

Trend analysis: no trend considering the following event is identified: no vacuum in packaging.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 sterile packaging had air and was not vacuum sealed well.No product was returned to zimmer biomet for in-depth analysis.According to the information received, the device was discarded at the hospital.Additional information was requested and is currently not available.Conclusion summary: no device or photos of the product have been received; therefore the condition of the component is unknown.The device manufacturing history records indicate that the products was accepted into final stock with no reported discrepancies.Additionally, the complaint history shows that no further similar event with this item# or lot# has ever been reported.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause cannot be determined.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: ANATOMICAL SHOULDER, HUMERAL HEAD, 52/23
• Type of Device: ANATOMICAL PRESS-FIT HUMERAL STEM
• 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: 6878361
• MDR Text Key: 86708297
• Report Number: 0009613350-2017-01310
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 01.04213.520
• Device Lot Number: 2681099
• Other Device ID Number: 00889024285828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2012
• 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