MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR FMRL 9X137; PROSTHETIC, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/16/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure 11 years post implantation due to tissue damage.During the revision, the surgeon encountered green and black debris consistent with metal on metal.Tissue was debrided from the interior of the joint and capsule.Damaged tissue and cyst formation was debrided from around and behind the acetabulum.The stem was found well fixed and the procedure was completed without complication.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).D10: us157850 item name m2a-magnum pf cup 50odx44id lot # 902300.157444 item name m2a-magnum mod hd sz 44mm lot # 708860.139256 item name m2a-magnum 42-50 tpr insrt std lot # 949800.Multiple mdr reports were filed for this event, please see associated reports.0001825034 - 2023 - 02986.0001825034 - 2023 - 02988.0001825034 - 2023 - 02989.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h6 component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on evaluation of the provided medical records review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: encountered discolored green and black debris consistent with mom debris.Cultured fluid- debrided damaged blackened tissue from the interior of the joint and the capsule.Femoral well fixed.Debridement of damaged tissue from around acetabulum.Behind acetabulum, extensive discoloration, cyst formation, damaged tissue.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.

• Brand Name: TAPERLOC POR FMRL 9X137
• Type of Device: PROSTHETIC, 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: 18344656
• MDR Text Key: 330721263
• Report Number: 0001825034-2023-02987
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830313
• 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: 03/14/2024

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: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 103203
• Device Lot Number: 149970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female