MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC133 MP T1 PPS SO; PROSTHESIS, HIP

Model Number N/A

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Occurred in (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.

Event Description

It was found at the distribution center that the sterile packaging was deformed due to the impact of the inner stem during distribution.No adverse events have been reported as a result of the malfunction.No patient involvement.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event is the packaging being subjected to too much heat during the shrink wrap operation due to being located in the shrink wrap tunnel for an excessive amount of time.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was found at the distribution center that the sterile packaging was deformed, likely due to excessive heat during the packaging process.No adverse events have been reported as a result of the malfunction.No patient involvement.No further information is available.

• Brand Name: TPRLC133 MP T1 PPS SO
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8330406
• MDR Text Key: 136148493
• Report Number: 0001825034-2019-00592
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• 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: 51-108060
• Device Lot Number: 6418305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1