MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 10.0 M T1; PROSTHESIS, HIP

Catalog Number 51-107100

Device Problems Positioning Failure (1158); Inadequacy of Device Shape and/or Size (1583)

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

Event Date 08/18/2022

Event Type  malfunction  

Event Description

It was reported the stem could only be placed 10 mm higher than the rasp position.In the surgeon's experience, he had seen them go a few millimeters higher, but this was the first time he had ever seen them 10 mm higher.The surgeon indicated a defect in product design (size).The surgery was completed using a stem implant one size smaller.There were no health consequences or impact to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Report source: japan.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; g3; h2; h3; h6 mechanical (g04) ¿ stem visual inspection found scratches to the taper of the stem but no other visible damage.Dhr was reviewed and no discrepancies related to the reported event were found.The investigation could not verify or identify any evidence of product contribution to the reported problem.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 10.0 M T1
• 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: 15464781
• MDR Text Key: 302779562
• Report Number: 0001825034-2022-02190
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304513433
• UDI-Public: (01)00880304513433(17)271126(10)6175976
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110400
• 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: 11/17/2022

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 Catalogue Number: 51-107100
• Device Lot Number: 6175976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2017
• 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