MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 TYPE1 PPS HO 10.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Problem with Sterilization (1596)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign source-(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 reported that there was debris in the sterile package.Attempts to obtain additional information were made; however, none was available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of photographs.The provided photographs of the products were reviewed and the reported event (debris in packaging) was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the product when it left zimmer biomet control was non-conforming.Investigation results concluded the root cause of the reported event is the operator not following instructions during the manufacturing process.A corrective action has been initiated to address the manufacturing deficiency.This product falls within the scope of a capa that is reviewing the debris in sterile packaging issue.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 HO 10.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8207837
• MDR Text Key: 131769627
• Report Number: 0001825034-2018-11405
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 51-104100
• Device Lot Number: 6402175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1