MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 TYPE1 PPS SO 15.0; HIP PROSTHESIS

Model Number N/A

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2018

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 upon inspection at warehouse, the implant was found to be through the inner and outer packaging.Attempts have been made, and no further information has been provided.

Event Description

No additional information available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product identified that the stem has protruded through the inner blister, outer blister and also the outer carton.Device history record was reviewed and no discrepancies were found.Root cause can be attributed to transit damage.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.

• Brand Name: TPRLC 133 TYPE1 PPS SO 15.0
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7658622
• MDR Text Key: 113022631
• Report Number: 0001825034-2018-04405
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: N/A
• Device Catalogue Number: 51-103150
• Device Lot Number: 3714386
• Other Device ID Number: (01) 0 0880304 49186 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1