MAUDE Adverse Event Report: TOTAL JOINT ORTHOPEDICS, INC. KLASSIC BIPOLAR FEMORAL HEAD

Model Number 3200.28.350

Device Problem Compatibility Problem (2960)

Patient Problems Pain (1994); Toxicity (2333)

Event Type  Injury  

Manufacturer Narrative

This issue is due to improper use of the klassic bipolar femoral head and klassic offset femoral stem by mating them with implants from stryker mdm x3 system, against the provided instructions for use of both systems.Use of these implants with the stryker implants is against supplied instructions and intended use and the design was not intended for such use.The rep has confirmed that the devices will not be recovered for further investigation.Without return of the implants physical investigation of the parts cannot be completed any further.Total joint orthopedics is submitting this as a voluntary report as our implants were used off label.

Event Description

Patient had pain starting 6 months ago.Originally diagnosed as psoas impingement and gave patient an injection.Injection didn't help so labs were done.Labs showed no infection and slightly elevated cobalt chromium levels at 7.Went to 12 lat month and cobalt chromium levels had almost doubled in a few months.Ct and mri were pretty normal.Revision surgery was done.Femoral stem showed damage below the taper.

• Brand Name: KLASSIC BIPOLAR FEMORAL HEAD
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): TOTAL JOINT ORTHOPEDICS, INC.; 1567 stratford ave; salt lake city UT 84106
• Manufacturer (Section G): TOTAL JOINT ORTHOPEDICS, INC; 1567 e stratford ave; salt lake city UT 84106
• Manufacturer Contact: bobbi siddoway ; 1567 e stratford avenue; salt lake city, UT 84106 ; 8014676070
• MDR Report Key: 10733739
• MDR Text Key: 213030835
• Report Number: 3008544874-2020-00001
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00814703012181
• UDI-Public: 00814703012181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/17/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2020
• Device Model Number: 3200.28.350
• Device Catalogue Number: 3200.28.350
• Device Lot Number: 197197
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 10/26/2020
• 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
• Patient Sequence Number: 1
• Treatment: KLASSIC OFFSET FEMORAL STEM 3103.04.000 TJ-4911141; MDM LINER 626-00-42E 52740704; RESTORATION ADM/MDM X3 INSERT FOR ADM/MDM; TRITANIUM HEMISPHERICAL CLUSTER HOLE SHELL
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR