MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 20.0; PROSTHESIS, HIP

Model Number N/A

Device Problems Problem with Sterilization (1596); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the sterile package was damaged.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  complaint sample was evaluated and the reported event was confirmed.Visual inspection found teh product is not vacuum sealed and tear in the packaging.Device history record was reviewed and no discrepancies were found.The root cause of the reported event is likely to be due to transit damage.A corrective action was initiated to address the reported issue.This product falls within the scope of a corrective action that is reviewing all current sterile barrier packaging configurations.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: TPRLC 133 MP TYPE1 PPS HO 20.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8537704
• MDR Text Key: 142754003
• Report Number: 0001825034-2019-01772
• Device Sequence Number: 1
• Product Code: KWA
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

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: 51-107200
• Device Lot Number: 3939016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1