MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS SO 6.0; PROSTHESIS, HIP

Catalog Number 51-100060

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/08/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: south korea.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported during a clinical study a patient underwent a left hip revision approximately eight months post implantation due to aseptic loosening, subsidence and a bone fracture.The stem was removed and replaced.Attempts have been made and no further information is available.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).Proposed component code: mechanical (g04)- stem.Visual examination of the returned product identified there are scratches on the body and to the taper.Bio-debris was noted to the porous coating.No other damage was noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: two weeks after the initial, the patient suffered a periprosthetic fracture from a fall due to walking in the rain.An orif was performed with no components revised.Eight months later, the patient was revised due to femoral loosening and subsidence, with a bone fracture noted.The stem was revised with an unknown product.The complaint was confirmed based on the provided medical records.Dhr was reviewed and no discrepancies related to the reported event were found.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 FP TYPE1 PPS SO 6.0
• 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: 18527275
• MDR Text Key: 333046212
• Report Number: 0001825034-2024-00109
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304498174
• UDI-Public: (01)00880304498174(17)321121(10)7391055
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K103755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-100060
• Device Lot Number: 7391055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: Asian