MAUDE Adverse Event Report: ZIMMER BIOMET, INC. R/H M/H STS 15X200MM DISTAL; PROSTHESIS, HIP

Catalog Number 11-108741

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Non-union Bone Fracture (2369); Osteolysis (2377); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported a patient underwent a hip revision approximately 15 years post implantation due to a stem and femur fracture.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: reported raking leave, and woke next morning with right hip pain.Mid stem implant fracture & periprosthetic fracture of lateral cortex.Cerclage wires fixating multiple previous periprosthetic fractures.More distal fracture has incomplete healing, extensive lucency around femoral component.Well seated acetabular component.Complaint confirmed based on the provided medical records.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause is unable to be established.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 additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: fracture at diaphyseal fitting portion of femoral component.Abductors scarred.Femoral & acetabular component well ingrown; poly was in good repair, no wear, noted 28mm head and 28mm liner.Diaphyseal fitting segment well ingrown in femoral shaft, unable to remove with kocher, several trephines used, trochanteric osteotomy completed, and removed component from femoral shaft.The additional information does not change the outcome of the previous investigation.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

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

There is no update to the prior event description provided.

• Brand Name: R/H M/H STS 15X200MM DISTAL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17630516
• MDR Text Key: 322027914
• Report Number: 0001825034-2023-02003
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2024

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: 01/31/2018
• Device Catalogue Number: 11-108741
• Device Lot Number: 722800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/25/2023; 10/04/2023; 04/11/2024
• Supplement Dates FDA Received: 09/28/2023; 10/10/2023; 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• Is the Device Single Use?: No
• 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: Male
• Patient Weight: 121 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White