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

Model Number N/A

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

Patient Problems Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 10/12/2022

Event Type  Injury  

Event Description

It was reported by patients¿ legal counsel that the patient underwent a right hip arthroplasty.It was reported that the patient has filed an unknown allegation.No hip revision has been reported at this time.No additional information.

Manufacturer Narrative

(b)(4).The product will not be returned to zimmer biomet for investigation at this time.The investigation is in process.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: 0001825034-2022-02781; 0001825034-2022-02783; 0001825034-2022-02784.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; g3; g6; d4; h2; h3; h4; h6 h6: component code: mechanical (g04) - stem no product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records were not provided.A review of the device history records 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.

Event Description

No further event information is 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: b1,b2,g3,b6,d6,e1,e2,e3,h2,h6 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 that the patient had a right side metal-on-metal total hip arthroplasty.Subsequently, the patient had a right total hip revision due to metal-on-metal.During the revision, a significant amount of inflamed synovial tissue was observed.All components were found to be osseointegrated and stable.No further complications were reported.No additional information.

Event Description

No further event information is 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: b4;g3;h2;h3;h6 no product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records were provided and reviewed by a health care professional.A review of the available records identified the following: significant amount of inflamed synovial tissue.All components osseo-integrated and stable.Synovectomy and irrigation to remove all abnormal tissue.The reported issue was confirmed based on the provided medical records.A review of the device history records identified no deviations or anomalies during manufacturing.The additional information does not change the outcome of the previous investigation.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: TAPERLOC POR FMRL 9X137
• 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: 15985924
• MDR Text Key: 305492684
• Report Number: 0001825034-2022-02785
• 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: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2023

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: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 103203
• Device Lot Number: 262880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/19/2022; 02/20/2023; 05/16/2023
• Supplement Dates FDA Received: 12/22/2022; 03/02/2023; 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Sex: Female