MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 TYPE1 PPS SO 17.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Concomitant medical products: 51-105110, stem, lot # 3560785.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11472.

Event Description

It was reported that upon inspection, the devices were found have debris inside the sterile packaging, as well as staining on the packaging.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical device: udi (b)(4).Report source: foreign source- (b)(6).Complaint sample was evaluated and the reported event was confirmed.The visual inspection of the returned products identified that foam inserts were damaged and there was poly debris.Dhr was reviewed and no discrepancies were found.Review of complaints history search for this part number identified no other complaints reported for the same lot.The root cause of the reported event is likely to be due to transit damage causing the foam to shed.This product falls within the scope of corrective action that is reviewing the packaging configurations at zimmer biomet, (b)(4).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 TYPE1 PPS SO 17.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8195739
• MDR Text Key: 131384640
• Report Number: 0001825034-2018-11471
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

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: 51-103170
• Device Lot Number: 3795964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1