MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 16X117MM; PROSTHESIS HIP

Catalog Number 51-145160

Device Problem Packaging Problem (3007)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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 during circulation of product that sterile packaging was found damaged.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TPRLC XR MP T1 PPS 16X117MM
• 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: 12547324
• MDR Text Key: 273797547
• Report Number: 0001825034-2021-02740
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00880304517356
• UDI-Public: (01)00880304517356(17)291016(10)6651792
• 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: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-145160
• Device Lot Number: 6651792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2019
• 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