MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 14X148MM MM T1; PROSTHETIC, HIP

Model Number N/A

Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Item # 51-103150 item name tprlc 133 t1 pps so15x150mm t1 lot# 3868576.Item # 51-105170 item name tprlc xr t1 pps17x154mm mm t1 lot# 6320261.(b)(6).Evaluation of the returned product/photographs provided 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 and black particles consistent with porous coating debris.The reported event is confirmed.Visual evaluation of the returned product/provided photos additionally identified damage to the sterile packaging blister and pouch was torn at the location of the notch cut for opening the pouch.Sterility has been compromised.Reported event has been confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be due to transit damage and 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.

Event Description

It was reported the distributor inspected circulated items and identified debris in sterile package.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TPRLC XR T1 PPS 14X148MM MM T1
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12484347
• MDR Text Key: 271789082
• Report Number: 0001822565-2021-02610
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304517158
• UDI-Public: (01)00880304517158(17)2703002(10)3982292
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/16/2021

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 Model Number: N/A
• Device Catalogue Number: 51-105140
• Device Lot Number: 3982292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1