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
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/12/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0002648920-2023-00211
• Device Sequence Number: 12276254
• Product Code: JDI
• UDI-Device Identifier: 00889024145788
• UDI-Public: (01)00889024145788(17)321226(10)65737202
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male