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

Model Number N/A

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)

Event Date 08/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).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.

Event Description

It was reported the taperloc subsided less than a week after initial implantation and the femur fractured.Patient was revised.No additional information.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Component code: mechanical (g04) ¿ stem.Visual examination of the provided pictures identified the head and stem had been removed.No other information could be obtained from the image.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.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 event information to report at this time.

• Brand Name: TPRLC 133 TYPE1 BM SO 12.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15454288
• MDR Text Key: 300217536
• Report Number: 0001825034-2022-02169
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00880304521278
• UDI-Public: (01)00880304521278(17)320602(10)7254414
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-113120
• Device Lot Number: 7254414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization