MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR FMRL LAT 10X140; PROSTHESIS HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: m2a 38mm mod hd -6mm nk # item 11-173660 lot 934760, m2a 38mmx48mm cup # item rd118848 lot 383250.Multiple mdr reports were filed for this event, please see associated reports:0001825034-2019-02684 and 0001825034-2019-02685.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported, patient turned wrong and experienced severe pain and spasm.Ct confirmed an avulsion of the lesser trochanter on the posterior cortex of the proximal femur.Further diagnostics revealed extremely high serum ion levels.The patient was revised 16 years post initial surgery for metallosis, elevated metal ion levels, difficulty ambulating, osteolysis, bone fracture, and pain.There was black staining of the tissue.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical report details that the patient turned wrong and has increased pain with spasms bilateral total hip prosthesis¿s appear well seated.Old healed right pubic ramus fracture.No acute fracture or dislocation identified.Ct report confirms there is an avulsion of the lesser trochanter on the posterior cortex of the proximal femur.Old healed pubic ramus fracture.No evidence of dislocation.Metal levels were extremely high.Implants themselves seemed stable radiographically back to 2012.There was black staining of the tissue.A complete synovectomy was done and metallosis removed.The acetabulum was inspected and there was no clinical evidence of loosening.There is osteolysis of the proximal femur with insufficiency fracture of the lesser tuberosity from the metallosis and osteolysis.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 available at the time of this report.

• Brand Name: TAPERLOC POR FMRL LAT 10X140
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8817582
• MDR Text Key: 151921566
• Report Number: 0001825034-2019-03188
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 11-103204
• Device Lot Number: 191410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 79