MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 BM SO 8.0; PROSTHETIC, HIP

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 07/04/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: ep-200152 act artic e1 hip brg 28x46mm; lot number 272470.650-1159 delta cer fem hd 28/-3mm t1; lot number is 2016111374.Report source foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01749.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 Description

It was reported that the patient underwent a revision procedure 5 months post implantation due to the stem subsiding which caused instability of the hip joint which resulted in a dislocation of the hip joint.There is no additional information available at the time of this report.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h6 mechanical (g04) - stem.H10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Impressions: femoral implant subsidence and suspected vertical orientation of the acetabular cup as noted.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 BM SO 8.0
• Type of Device: 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: 17405751
• MDR Text Key: 319856953
• Report Number: 0001825034-2023-01748
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304498761
• UDI-Public: (01)00880304498761(17)261214(10)3925828
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• 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: 10/26/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 51-110080
• Device Lot Number: 3925828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female