MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 2 130 MM STEM LENGTH; PROSTHETIC, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 08/12/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 802203602 zb 12/14 cocr hd 36mm x +0 lot # 2994139, 010000857 g7 neutral e1 liner 36mm e lot # 7351408, 110010244 g7 osseoti 3 hole shell 52mm e lot # 7506421.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02391, 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.H3 other text: device location is unknown.

Event Description

It was reported that the patient underwent a revision procedure 26 days post implantation due to a dislocation of the liner from the head that resulted in the stem dislodging out of the canal half-way.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no 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: left total hip arthroplasty with superior and likely posterior dislocation.Incomplete implementation of the femoral component within the proximal femur.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.

Event Description

There is no update to the prior event description provided.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 2 130 MM STEM LENGTH
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17692906
• MDR Text Key: 322764444
• Report Number: 0002648920-2023-00211
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024145788
• UDI-Public: (01)00889024145788(17)321226(10)65737202
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K191735
• 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: 12/21/2023

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: 00811400210
• Device Lot Number: 65737202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2022
• 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): Hospitalization; Required Intervention
• Patient Sex: Male