MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 09/01/2022

Event Type  Injury  

Event Description

It was reported that patient underwent a left hip revision approximately 8 years post implantation due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: 65771101220 ¿ m/l taper stem ¿ 62554301.00875101036 ¿ xlpe liner ¿ 62338614.00625006530 ¿ bone screw ¿ 62640335.00875705201 ¿ cup ¿ 62083003.Product is not being returned to zimmer biomet for the investigation as the product was not returned by the attorney.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-0515 and 0001822565-2023-00519.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h6: proposed component code: mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Review of the provided legal documents identified an initial left tha occurred, along with a revision approximately 8 years later.The head and liner were noted to be revised.The stem remained implanted, however there are unknown allegations against the stem within the legal documents.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

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 on (b)(6), 2014.A revision was performed on (b)(6), 2022 due to metallosis, osteolysis, corrosion, and tissue damage.During the revision, a granular yellow sandy debris was noted in the capsule and debrided and black debris to the taper.The head and liner were explanted and new products were placed.Root cause unchanged.This complaint was confirmed based on the provided medical records.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.

Event Description

It was reported that the patient underwent a left hip revision procedure approximately 8 years and 4 months post implantation due to metal related pathology, osteolysis, corrosion, wear, and tissue damage.Findings in the operative report state there was granular yellow sandy debris in the capsule as well as into the greater trochanteric bed and the attachment of the medius.This was all debrided.There was black corrosion of the taper.The head and liner were exchanged without complication.There is no additional information available at the time of this report.

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 proposed component code: mechanical (g04) - head.Visual inspection of the as returned head taper shows debris and wear.The head was submitted for further analysis.Analysis determined consensus; this taper was assigned a modified goldberg score of 3.A score of 3 corresponds to fretting on more than a third of the surface and/or aggressive local corrosion attack with corrosion debris.Root cause unchanged.This complaint was confirmed based on the provided medical records and returned devices.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 HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• 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: 16452632
• MDR Text Key: 310344330
• Report Number: 0002648920-2023-00026
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/05/2024

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: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00801803601
• Device Lot Number: 62498308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 03/13/2023; 05/23/2023; 06/15/2023; 01/02/2024
• Supplement Dates FDA Received: 03/17/2023; 06/15/2023; 06/21/2023; 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2013
• 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): Hospitalization; Required Intervention
• Patient Sex: Female