MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM LOW DEMAND/FRACTURE CEMENTED; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent hip surgery at the end of last year.The patient was revised at the beginning of the year due to dislocation.The cemented ld/fx was dislodged from cement mantle during closed reduction of a dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 110035368 biomet bc r 1x40 us y49aaa0309, 00785901200 distal centralizer 12 mm o.D.65509002, 00781805100 endo femoral head 12 / 14 taper 65499504 and 00781809900 endo femoral head adaptor 12 / 14 taper plus 7.0 mm neck length 65366691.Multople mdr reports were filed for this event, please see associated reports: 0002648920-2023-00013.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Event or Problem Description
No additional event information to report at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left hip arthroplasty dislocation and loosening of the cemented femoral implant 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMORAL STEM LOW DEMAND/FRACTURE CEMENTED
• Common Device Name: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16362479
• Report Number: 0001822565-2023-00348
• Device Sequence Number: 17869634
• Product Code: JDI
• UDI-Device Identifier: 00889024135895
• UDI-Public: (01)00889024135895(17)300908(10)64874473
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K955473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2023

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: 00783301400
• Device Lot Number: 64874473
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 02/01/2023; 03/09/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 02/13/2023; 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• 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: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male