MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM CEMENTED REVISION/CALCAR; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Unspecified Infection (1930)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 802203202 zb 12/14 cocr hd 32mm x +0 2999580; 00800595232 acetabular cup for cemented use only id 32 mm snap-in od cup with spacers 55 mm 63608860; 00223200418 cable cerclage cable with crimp 1.8 mm dia.635 mm length 65573115; 00223200418 cable cerclage cable with crimp 1.8 mm dia.635 mm length 65576873.G2: foreign: australia.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.
Event or Problem Description
It was reported the patient underwent a hip arthroplasty and was revised two months post implantation due to an underlying infection and subsequent femur fracture due to a fall.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.H6: proposed 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 for the stem identified no deviations or anomalies during manufacturing.All sterile certifications for each device were conforming to specifications.Images assessed but not sent to mmi as the background of the or obscures the view of the implants in the xrays.Sending the images would not enhance the investigation.It was reported the patient suffered a femur fracture due to a fall.However, as the reason for the fall is unknown, a definitive root cause cannot be identified.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: FEMORAL STEM CEMENTED REVISION/CALCAR
• Common Device Name: PROTHESIS, 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: 17229858
• Report Number: 0002648920-2023-00136
• Device Sequence Number: 7091469
• Product Code: JDI
• UDI-Device Identifier: 00889024140035
• UDI-Public: (01)00889024140035(17)320704(10)65473528
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K210842
• 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): 10/20/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00787101361
• Device Lot Number: 65473528
• 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: 06/04/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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: 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 73 KG