MAUDE Adverse Event Report: ZIMMER GMBH ALLOFIT ALLOCLASSIC A SHELL WITH POLAR SCREW PLUG UNCEMENTED 56/KK; ALLOFIT SHELL

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Information (3190)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The device history records were reviewed and found to be conforming.The device history records were reviewed and found to be conforming.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.Additional information has been requested and is currently not available.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted a allofit alloclassic a shell with polar screw plug uncemented 56/kk on an unknown side (exact date not reported).Packaging problem was existing due to absence of vacuum and they used other item.

Manufacturer Narrative

Trend analysis: no trend considering the following event is identified: no vacuum in bag.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it was reported that when the customer opened the package they recognised that no vacuum of the inner plastic packaging was existing anymore.They used another item.No case-relevant documents received.Devices analysis - the allofit alloclassic shell and the corresponding polar screw plug have been returned for investigation.Visual examination shows that the polar screw plug is still in its original condition and is packed according to the specifications (with vacuum).The bag of the allofit alloclassic shell is already cut and opened.Blood residues are visible on the bags.No other conspicuousnesses can be detected.Root cause analysis root cause determination using dfmea: - fehlende oder unzureichende vakuumierung due to beutellumen nicht evakuiert => possible: since the bag of the allofit alloclassic shell was returned already cut and opened no determination can be made.- fehlende oder unzureichende vakuumierung due to produkt nicht ausreichend fixiert, daher abriebe des beutels am produkt; verunreinigung des produkts => possible: since the bag of the allofit alloclassic shell was returned already cut and opened no determination can be made.Conclusion summary the complaint could not be confirmed.Since the bag of the allofit alloclassic shell was returned already cut and opened no determination can be made.The bag of the polar screw plug is still in its original condition and packed according to the specifications (with vacuum).The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: ALLOFIT ALLOCLASSIC A SHELL WITH POLAR SCREW PLUG UNCEMENTED 56/KK
• Type of Device: ALLOFIT SHELL
• 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: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6618031
• MDR Text Key: 76979247
• Report Number: 0009613350-2017-00798
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 4247
• Device Lot Number: 2896209
• Other Device ID Number: 00889024166042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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