MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 12X144MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 04/19/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the sterile packaging was found to be punctured.A second device was used to complete the procedure.No adverse events have been reported as a result of this malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Evaluation of the returned product confirmed that there is debris inside the sterile packaging which is consistent with the appearance of porous coating.Outer sterile packaging has not been returned, and no damage has been found on the sterile packaging.The reported event is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the product when it left zimmer biomet was conforming to specifications.The root cause of the reported event is likely due to transit damage.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: TPRLC 133 T1 PPS SO 12X144MM
• Type of Device: PROSTHESIS, 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: 14397869
• MDR Text Key: 292033516
• Report Number: 0001825034-2022-01213
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00880304491823
• UDI-Public: (01)00880304491823(17)290924(10)6636470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• 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: 51-103120
• Device Lot Number: 6636470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2019
• 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