MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER OFFSET SIZE 3 180 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately 2 weeks post implantation due to loosening caused by peri-prosthetic fracture after an unknown fall.Patient did not experience any sort of instability or issues related to the implant prior to the fall.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Report source: foreign: australia.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 2648920.
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 2648920.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER OFFSET SIZE 3 180 MM
• Common Device Name: PROSTHESIS, 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: 15606136
• Report Number: 0002648920-2022-00216
• Device Sequence Number: 2328745
• Product Code: JDI
• UDI-Device Identifier: 00889024145832
• UDI-Public: (01)00889024145832(17)310607(10)65026486
• 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: 2022
• Device Explanted Year: 2022
• 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): 11/10/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00811400318
• Device Lot Number: 65026486
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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: CAT# 00223200418 CABLE LOT# 64590498; CAT# 00223200418 CABLE LOT# 65232765; CAT# 00801102028 CEMENT LOT# 64214810; CAT# 00875201236 RIM LINER LOT# 65252396; CAT# 00875705601 POROUS SHELL LOT# 64932384; CAT# 32833305500 CENTRALIZER LOT# 64590498; CAT# 802203602 FEMORAL HEAD LOT# 3010464
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male