MAUDE Adverse Event Report: STRYKER CORP METAL-ON-METAL HIP IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/ CERAMIC/POYLMER

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

Patient Problems Scar Tissue (2060); Swelling (2091); Thrombus (2101); Complaint, Ill-Defined (2331); Toxicity (2333); No Code Available (3191)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Dr.(b)(6) replaced ball and socket components, originally placed in (b)(6) 2008.Right hip.Dr.(b)(6) stated that the sciatic nerve had been traumatized during the extended procedure to clear the damaged tissue and took over two hours longer.The right foot did not respond to physical therapy in the hospital, so i was released with an afp brace.Further, testimony and continued disability caused the dr.To ¿reattack¿ the damaged right hip from the rear on (b)(6) 2019.During this procedure scar tissue was removed from the sheath on the nerve manually through the 8 inch incision.Electric stimulator of the nerve caused toes to move.Still treatment for lower extremity blood clots and foot swelling continue into the sixth month, with minor improvement.

• Brand Name: METAL-ON-METAL HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/ CERAMIC/POYLMER
• Manufacturer (Section D): STRYKER CORP
• MDR Report Key: 9676860
• MDR Text Key: 178208751
• Report Number: MW5092796
• Device Sequence Number: 2
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/30/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 79 YR
• Patient Weight: 76