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

Model Number	3200.28.350
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Codes	Pain (1994); Toxicity (2333)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: FEMORAL HEAD
• Manufacturer (Section D): TOTAL JOINT ORTHOPEDICS, INC.; 1567 stratford ave; salt lake city UT 84106
• MDR Report Key: 10733739
• Report Number: 3008544874-2020-00001
• Device Sequence Number: 16586336
• Product Code: KWY
• UDI-Device Identifier: 00814703012181
• UDI-Public: 00814703012181
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K143113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR