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

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 09/23/2022

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 301733728
• Report Number: 0002648920-2022-00216
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024145832
• UDI-Public: (01)00889024145832(17)310607(10)65026486
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male