MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM TM SHELL UNI 56 KK; PROSTHESIS HIP

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported while opening package in operating room during surgery.Surgeon noticed that on inner package (aluminium foil) there were small hole.No adverse event/harm to patient.No further information available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated:  complaint sample was evaluated and the reported event was not confirmed.Visual evaluation of the returned product confirms the presence of a hole in the foil pouch.However, the returned carton box does not feature any damage.The foil pouch is torn opened and the hole, a semi-circular tear, is located over where the foil covers the polar hole of the shell.Also, close to the hole there is an imprint of the porous surface of the shell showing through, which indicates that the foil was pressed against the porous surface of the shell.Device history record (dhr) was reviewed and no discrepancies were found.The packaging of the product was handled and it cannot be determined whether the damage observed on the foil pouch was present before its being opened.Therefore, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: CONTINUUM TM SHELL UNI 56 KK
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7861413
• MDR Text Key: 119796852
• Report Number: 0001822565-2018-04585
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PK151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

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 Model Number: N/A
• Device Catalogue Number: 00875705600
• Device Lot Number: 77006466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 12/12/2018
• 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