MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 20X160MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported black dust was found inside of inner package.The device was not used and the procedure was completed with a similar device without significant delay to surgery.No further information is available at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Upon visual inspection of the returned packaging, black debris is present in the sterile packaging.The black debris appears to be porous coating transferred from the device.A blood mark was identified on the returned packaging which could be from the procedure as it was opened during a surgery.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to friction during transit causing the porous coating to transfer from the implant to the 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.

• Brand Name: TPRLC 133 T1 PPS HO 20X160MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8767324
• MDR Text Key: 150261439
• Report Number: 0001825034-2019-02900
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

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: 51-104200
• Device Lot Number: 3899173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 120