MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 TYPE1 BM SO 12.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant products: catalog number: 110010264 lot number: 6468272 brand name: g7 osseoti multihole 52mm; catalog number: 010000849 lot number: 6983717 brand name: g7 neutral e1 liner 32mm e; catalog number: 163668 lot number: 487900 brand name: 32mm mod head cocr -3mm.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to infection approximately 2 years post implantation.Additional information on the reported event is unavailable.

Event Description

Upon reassessment of the reported event, it was determined the device did not contribute to the reported event and is not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined the device did not contribute to the reported event and is not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: TPRLC 133 TYPE1 BM SO 12.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): .; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12788752
• MDR Text Key: 280599522
• Report Number: 0001825034-2021-03091
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00880304521278
• UDI-Public: (01)00880304521278(17)290428(10)6537040
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-113120
• Device Lot Number: 6537040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2019
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male