MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 16X152MM T1 PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Mfr site: (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. Device not yet received.

Event Description

It was reported that the product packaging was found to be nonconforming. The incoming inspection team found debris and blood like debris in the sterile package. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TPRLC 133 T1 PPS SO 16X152MM T1
• 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: 11343105
• MDR Text Key: 232370236
• Report Number: 0001825034-2021-00530
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304489691
• UDI-Public: (01)00880304489691(17)301212(10)6839312
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 51-103160
• Device Lot Number: 6839312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI