MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 16X117MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Incomplete or Missing Packaging (2312); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the 16 tl micro 123 stem did not have outer plastic.The inner packaging was sealed, however, when the nurse peeled off inner layer onto field the stem plastic was open and stem was dirty with white flakes all over it.No adverse consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d4, d9, g3, g6, h2, h3, h4, h6, h10 the event was confirmed with product received.Visual examination of the returned product found the blister packaging had been opened.The inner pouch had been opened and white debris visually consistent with debris from the foam packaging was visible inside.Black stains/debris was also visible inside the pouch consistent with debris from the porous coating.The sterile barrier of all devices was not intact.As the product was returned opened, the sterility or breach thereof cannot be determined.  device history record was reviewed and no discrepancies relevant to the reported event were found.The condition of the device when it left zimmer biomet cannot be determined, as the product was returned opened.Previous investigations into the reported event/similar issue found the root cause to be attributed to transit damage, however, a definitive root cause cannot be determined.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 XR MP T1 PPS 16X117MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11804782
• MDR Text Key: 249971228
• Report Number: 0001825034-2021-01419
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• 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: 06/14/2021

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 Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 51-145160
• Device Lot Number: 2901574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1