MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 8X101MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that there was debris in the sterile package.No adverse events have been reported as a result of the malfunction 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/photographs provided confirmed foreign debris is present inside the sterile packaging, and the sterile packaging was opened.Complaint sample was evaluated and the reported event was confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was returned opened.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 further event information available at the time of this report.

• Brand Name: TPRLC 133 MP T1 PPS SO 8X101MM
• 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: 14073943
• MDR Text Key: 289005593
• Report Number: 0001825034-2022-00837
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304515314
• UDI-Public: (01)00880304515314(17)310831(10)7091757
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• 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: 51-108080
• Device Lot Number: 7091757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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