MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS SO 4.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 00615.0001825034 - 2020 - 00616.0001825034 - 2020 - 00618.

Event Description

It was reported the warehouse circulated their stock items and identified debris in sterile packages.No hospitals or patients were involved.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Evaluation of the returned product confirmed there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Review of the device history records for the reported items identified no deviations or anomalies related to the reported issue during manufacturing.The likely condition of the products when they left zimmer biomet was conforming to specification.The root cause of the reported issue is attributed to transit damage causing the foam packaging to become abraded and shed.A corrective action was opened to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this 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.Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided.

Event Description

Upon further investigation, it has been determined that the debris is the sterile packaging meets the acceptable criteria specifications.This event is no longer considered reportable.Therefore, the initial report should be voided.

• Brand Name: TPRLC 133 MP TYPE1 PPS SO 4.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9695012
• MDR Text Key: 201888956
• Report Number: 0001825034-2020-00617
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• 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: 51-108040
• Device Lot Number: 2980438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1