MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM CEMENTED STD COLLAR 12/14 NECK TAPER STD NECK OFFSET SIZE 12 125MM; PROSTHESIS, HIP

Catalog Number 00785001200

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); Unequal Limb Length (4534)

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

Cmp- (b)(4).Ref 00620205420 lot 63585570.Tm acetabular system ref 00625006525 lot 64414177.Self tapping bone screw- 6.5x25mm.Ref 00625006535 lot j6728714.Self tapping bone screw ¿ 6.5x35mm.Ref 00630505036 lot 64505457.Trilogy liner ref 00877503601 lot 3006382.Biolox delta ceramic head, s 36/-3.5, taper 12/14 ref 00785900900 lot 62543442.Versys distal centralizer 9mm od ref 00504905500 lot 63575201.Quick use femoral bone cement w/2 allen medullary cement plugs.Ref 414703 lot 30183.Clear mix triple ¿ vacuum mixing system.The device will not be returned for analysis.However; an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.

Event Description

It was reported that the patient underwent a left revision surgery approximately 2 years post implantation due to pain, limp and radiographic evidence of a fracturing cement mantle and stem substance.During the surgery it was noted that the stem was protruding out of the femoral cortex and the left lag was longer than the right and poor bone quality was noted.The stem was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; h2; h3; h4; h6.H6 proposed component code: mechanical (g04)- stem no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient started to experience pain and a limp.An x-ray showed the cement mantle fractured and the stem subsided.A revision was performed and bone remodeling was found, as well as the stem protruding out of the femoral cortex.The bone quality was very poor.The shell was found to be well fixed, and a new zimmer liner, head, and stem were placed.Review of the device history record identified no deviations or anomalies during manufacturing.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.

• Brand Name: FEMORAL STEM CEMENTED STD COLLAR 12/14 NECK TAPER STD NECK OFFSET SIZE 12 125MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15412506
• MDR Text Key: 299794487
• Report Number: 0001822565-2022-02639
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 00785001200
• Device Lot Number: 62524103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 10/03/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2013
• 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: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 58 KG