MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 13X146MMTP; PROSTHESIS, HIP

Catalog Number 51-103130

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/21/2022

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 outside plastic and box of the implant wasn't damaged, nor was the plastic container inside.However, the plastic around implant was damaged with holes, and there was black and white debris inside the plastic in with the implant.The surgeon did not use the product and had to open a different implant to complete the procedure.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.The following sections were updated/corrected updated: d4; g3; h2; h3; h4; h6 visual evaluation of the returned product/photographs provided identified damage to sterile pouch with debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging and the porous coating.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The 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.

Event Description

No additional information on the reported event.

• Brand Name: TPRLC 133 T1 PPS SO 13X146MMTP
• 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: 13537655
• MDR Text Key: 286764000
• Report Number: 0001825034-2022-00342
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00880304489677
• UDI-Public: (01)00880304489677(17)290408(10)6523826
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-103130
• Device Lot Number: 6523826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male