MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Failure of Implant (1924); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: unknown versys femoral head unknown multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2023 - 02381.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the patient¿s legal counsel that the patient underwent a right hip arthroplasty.Subsequently, the patient underwent a revision procedure eleven years post implantation due to unknown reasons.Attempts have been made and it was reported that no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.Unable to confirm complaint.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 additional event information to report at this time.

Event Description

It was reported the patient underwent a right total hip arthroplasty.Subsequently, the patient was revised eleven (11) years post implantation due to metal related pathology, elevated metal ion, pseudotumor, corrosion of trunnion and tissue damage.Liner and head revised and exchanged.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.D10: 00801803202 femoral head sterile product do not resterilize 12/14 taper 61670799.00875705202 52mm o.D.Size ii porous uncemented with multi-holes shell use with ii liners 61629434.00625006520 bone screw self-tapping 6.5 mm dia.20 mm length 61738443.00625006535 bone screw self-tapping 6.5 mm dia.35 mm length 61738504.00875201032 32mm i.D.Size ii elevated rim liner use with 52mm o.D.Size ii shell 61477097.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Proposed component code: mechanical (g04)- stem.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed, and the patient was revised ten years post implantation due to elevated metal ions and a pseudotumor.During the revision, tissue damage and bone loss to the femur was identified.Corrosion was noted to the trunnion.The liner and head were explanted and replaced with zb products.This complaint was confirmed based on the provided medical records.Root cause unchanged.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.

Event Description

No additional event information to report at this time.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Type of Device: PROTHESIS, 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: 17664924
• MDR Text Key: 322473265
• Report Number: 0001822565-2023-02380
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192660
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00771100900
• Device Lot Number: 61559510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2010
• 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 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 86 KG