MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 18X156MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

It was reported stem was opened, and the packaging showed signs of wear.The surgeon decided not to implant.No additional information on the reported event.

Manufacturer Narrative

(b)(4).Evaluation of the returned product confirmed there is white debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.There is debris inside the sterile packaging which is consistent with the appearance of porous coating.Identified damage to the sterile packaging (pouch).Sterility cannot be confirmed as the blister package was opened upon arrival.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design 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 XR T1 PPS 18X156MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15732496
• MDR Text Key: 304344970
• Report Number: 0001825034-2022-02494
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304517196
• UDI-Public: (01)00880304517196(17)260302(10)3739614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2022

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: 51-105180
• Device Lot Number: 3739614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1