MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 3 130 MM STEM LENGTH; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 10/01/2023

Event Type  Injury  

Event Description

It was reported the patient underwent an initial left total hip arthroplasty.Subsequently, the patient was revised approximately 3 months later due to a displaced periprosthetic femur fracture.Intraoperatively, loosening of the stem as well as significantly osteoporotic bone were noted.The head and stem were exchanged and the fracture was reduced and stabilized.There were no complications and further information is unknown at this time.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).G2: foreign: australia.Cat# 802203603 lot# 3017505 zb 12/14 cocr hd 36mm x +3.5.Cat# 00801102032 lot# 65725543 allen medullary cement plugs 1-32 mm diameter flange/16mm diameter core store in cool dry place.Cat# 110010244 lot# 7515464 g7 osseoti 3 hole shell 52mm e.Cat# 010000936 lot# 6854152 g7 hi-wall e1 liner 36mm f.Cat# 66044274 lot# d105 palacospro 75g.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional 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 record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.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 Description

No further information at the time of this report.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 3 130 MM STEM LENGTH
• 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: 17984364
• MDR Text Key: 326244628
• Report Number: 0002648920-2023-00255
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024145825
• UDI-Public: (01)00889024145825(17)301004(10)64786085
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K200823
• 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: 12/13/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00811400310
• Device Lot Number: 64786085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female