MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL OSTEONECROSIS INTERVENTION IMPLANT; ON ROD IMPLANTS

Model Number N/A

Device Problems Use of Device Problem (1670); Metal Shedding Debris (1804)

Patient Problem Pain (1994)

Event Date 08/15/2007

Event Type  Injury  

Manufacturer Narrative

Mfr report # 3005751028 - 2017 - 02740 was submitted on 11/28/2017 for the revision of the device.Addition information was provided about the remnant identified post-op.Device location unknown.

Event Description

It was reported that patient underwent left total hip arthroplasty approximately 6 months post implantation.However, during the surgery, remnant of metal was left in the hip.The metal is continuing to give the patient issues, as reported by the patient "severe pain on a scale 1-10 it is higher, it comes and goes".Hip has to be replaced to be able to get the metal particles out.

Manufacturer Narrative

There was no evidence that the trabecular metal osteonecrosis intervention implants failed to perform as intended.Based on the available information, a definitive cause of the trabecular metal osteonecrosis intervention implants contribution to the revision cannot be determined with certainty.The trabecular metal osteonecrosis intervention implant is zimmer tmt design controlled product.Review of the trabecular metal osteonecrosis intervention implant manufacturing record indicated no anomalies were reported.It was noted in the complaint that metallic debris were detected post revision.The available x-rays were reviewed by hcp, and it became evident that the removal of the tm rod described in the complaint was not performed per surgical technique.The surgical technique has note saying that ¿do not cut through the implant with the saw as this will generate large amounts of trabecular metal debris¿.Should additional information be obtained to further this investigation, this report shall be updated.

• Brand Name: TRABECULAR METAL OSTEONECROSIS INTERVENTION IMPLANT
• Type of Device: ON ROD IMPLANTS
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: bhairavi patel ; 10 pomeroy road; parsippany, NJ 07054 ; 8622611175
• MDR Report Key: 7214701
• MDR Text Key: 98052246
• Report Number: 3005751028-2018-00015
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: N/A
• Device Catalogue Number: 00119708510
• Device Lot Number: 60486162
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 42 YR
• Patient Weight: 82