MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS SO 9.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Problem with Sterilization (1596)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

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.

Event Description

It was reported upon incoming inspection at the distributorship, that debris was found in the sterile package.No adverse events have been reported as a result of the malfunction.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  complaint sample was evaluated and the reported event was confirmed.The returned product was visually inspected and the reported event (debris in packaging) was confirmed.Device history record was reviewed and no discrepancies were found.The likely condition of the product when it left zimmer biomet control was non-conforming.The root cause of the reported event is the operator not following instructions during the manufacturing process.A corrective action was initiate to address the manufacturing deficiency.This product falls within the scope of a corrective action which is reviewing all bridgend complaints for debris in packaging.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 SO 9.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8436362
• MDR Text Key: 139325276
• Report Number: 0001825034-2019-01311
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• 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: 51-106090
• Device Lot Number: 6479479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1