MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 TYPE1 BM HO 14.0; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Fall (1848); Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)

Event Date 10/16/2023

Event Type  Injury  

Event Description

It was reported that approximately six days post implantation, the patient underwent a revision surgery due to falling and fracturing their femur during rehabilitation.The stem was revised.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: cat# 650-0661 lot# 3149982 delta ceramic fem hd 36/0mm.G2: foreign ¿ australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further information is available at the time of this report.

Manufacturer Narrative

(b)(4).H6: component code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on review of the provided x-rays.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were reviewed by a health care professional and identified the following: sizing of the implant is appropriate.Osteopenia may have contributed to the patient's fracture and eventual subsidence of the hardware.A definitive root cause cannot 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.

• Brand Name: TPRLC 133 TYPE1 BM HO 14.0
• 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: 18085481
• MDR Text Key: 327546253
• Report Number: 0001825034-2023-02606
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304521414
• UDI-Public: (01)00880304521414(17)320411(10)7234311
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 51-114140
• Device Lot Number: 7234311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization