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

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377); Numbness (2415); Metal Related Pathology (4530)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: (b)(6) item name m2a-magnum 42-50mm tpr insrt-3 lot # 604750.(b)(6) item name m2a-magnum mod hd sz 44mm lot# 356540.(b)(6) item name m2a-magnum pf cup 50odx44id lot # 580340.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01914, 0001825034 - 2023 - 01913, 0001825034 - 2023 - 01912.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.H3 other text : device location is unknown.

Event Description

It was reported that the patient underwent a revision procedure 15 years and 3 months post implantation due to pain, numbness and metal on metal articulation.During the revision a large pseudotumor was encountered as well as osteolysis of the proximal femur.Femoral head was cold-welded to the stem.Acetabular components demonstrated to be well healed and seated.Revision was completed without complications.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: infection workup negative, metal on metal articulation with osteolysis of the proximal femur, asa ii, general anesthesia, ebl 100cc, new incision site posterior approach, large pseudotumor, femoral head was cold-welded to the stem, cables were placed distally to prevent further propagation, acetabular components demonstrated well healed and seated, portion of femur, synovium, and synovial sent to pathology.Trial implants showed excellent balance of leg-length inequality and hip stability.The patient transferred to recovery in stable condition.There were no intraoperative complications reported.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: 17551090
• MDR Text Key: 321224305
• Report Number: 0001825034-2023-01911
• 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: 12/05/2023

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: Lay User/Patient
• Device Expiration Date: 03/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 103203
• Device Lot Number: 529210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2007
• 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): Required Intervention; Hospitalization
• Patient Sex: Female