MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 11.0; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the doctor broached to a size 11, the size 11 stem and coating caused it to sit proud.After attempting to lateralize the canal, he had the rep open a size 10 stem for implantation which still sat 2mm proud.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
There is no additional event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 d1 d4 g3 g6 h2 h11.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h6 proposed code: mechanical (g04) - stem h11 visual examination of the provided pictures identified the stems inserted in the patients joint during the surgical procedure.The femoral components are seen sitting proud.There were no images provided of the femoral components on it's own.Unable to confirm part/lot of component shown in each image.No product was returned; visual and dimensional evaluations of the coating thickness could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event medical records were not provided.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 MP TYPE1 PPS HO 11.0
• Common Device Name: PROSTHETIC, 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: 19850395
• Report Number: 0001825034-2024-01914
• Device Sequence Number: 6820926
• Product Code: KWA
• UDI-Device Identifier: 00880304513457
• UDI-Public: (01)00880304513457(17)330706(10)7530750
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-107110
• Device Lot Number: 7530750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 11/05/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 10/03/2024; 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK STEM
• Patient Sex: Female