MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 15X150MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Visual inspection of the returned product found the blister seal to be intact.The foam inserts have been damaged such that foam debris are present within the blister.Visual inspection confirmed that the inner pouch containing the stem is torn such that the inner sterile barrier is compromised.Complaint sample was evaluated and the reported event was confirmed.Device history record was reviewed and no discrepancies were found.The likely condition of the part when it left zimmer biomet control is considered conforming based on the evaluation of the returned product, the dhr review, and the potential transit age of the device.The root cause for the presence of foam debris within the sterile cavity as well as the damaged inner pouch is attributed to damage during transit.This device falls within the scope of a corrective action which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this corrective action, the pouch is being improved to use a stronger material (nylon), and foam end caps are being added.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.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

It was reported that the sterile package was damaged and the sterility of the device has been compromised.Additional information on the reported event is unavailable.

• Brand Name: TPRLC 133 T1 PPS SO 15X150MM T1
• 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: 9952854
• MDR Text Key: 187876488
• Report Number: 0001825034-2020-01595
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304491861
• UDI-Public: (01)00880304491861(17)270420(10)6032512
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2020

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: 51-103150
• Device Lot Number: 6032512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• 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