MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 1 130 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); Osteopenia/ Osteoporosis (2651)

Event Date 01/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803203 63541308 femoral head sterile product do not resterilize 12/14 taper.00630506032 62621333 liner standard 32 mm i.D.For use with 60 mm o.D.Shell.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation; due to the device is unavailable by hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent initial hip arthroplasty, subsequently; the patient was revised approximately 5 years post implantation due to periprosthetic fracture.X-ray review found suspected medial femoral periprosthetic fracture with apparent femoral implant loosening and osteopenia.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays received.Review of the available records identified suspected medial femoral periprosthetic fracture with apparent femoral implant loosening.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

Event Description

No further event information available at the time of this report.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 1 130 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13334795
• MDR Text Key: 284316571
• Report Number: 0002648920-2022-00019
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/03/2022

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: 00811400110
• Device Lot Number: 63552666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2016
• 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