MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 12.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

Event Type  malfunction  

Event Description

It was reported that during a right hip procedure, the stem component was found to seat abnormally high.There was no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Product will not be returning to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - stem; the reported event was unable to be confirmed due to no product return, images, or medical records to evaluate.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause could not 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 information.

• Brand Name: TPRLC 133 MP TYPE1 PPS HO 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: 16989637
• MDR Text Key: 316139620
• Report Number: 0001825034-2023-01069
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304513471
• UDI-Public: (01)00880304513471(17)330127(10)7433966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-107120
• Device Lot Number: 7433966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• 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