MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 16X117MM 117MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03270, 0001825034-2020-03271, 0001825034-2020-03272, 0001825034-2020-03273, 0001825034-2020-03274, 0001825034-2020-03275, 0001825034-2020-03276, 0001825034-2020-03277, 0001825034-2020-03278, 0001825034-2020-03279, 0001825034-2020-03280, 0001825034-2020-03281.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 that there was debris in the sterile packaging.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon initial risk assessment, it has been determined that the reported device did not cause or contribute to the event.Event is no longer considered reportable, and initial report should be voided.

Event Description

Upon initial risk assessment, it has been determined that the reported device did not cause or contribute to the event.Event is no longer considered reportable, and initial report should be voided.

• Brand Name: TPRLC XR MP T1 PPS 16X117MM 117MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10437164
• MDR Text Key: 203853602
• Report Number: 0001825034-2020-03271
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• 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: 51-145160
• Device Lot Number: 3852640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1