MAUDE Adverse Event Report: ZIMMER BIOMET ACETABULAR SYSTEM

Model Number 00875705002

Device Problem Metal Shedding Debris (1804)

Patient Problems Unspecified Infection (1930); Pain (1994); Toxicity (2333); Fluid Discharge (2686); Test Result (2695)

Event Date 11/18/2011

Event Type  Injury  

Event Description

If original product(hardware) not failed, revision surgery would have not been needed and no infection/surgery would have happened.I had left hip replacement done in (b)(6) 2014.Dr.(b)(6) used products mfg by (b)(4).About 15 mins later, i started experiencing pain in my hip (left) and left groin area.An x-ray showed all hardware in place.A cortisone injection into my left hip was done on (b)(6) 2013.Blood work also done at this time.Blood test showed high levels of cobalt and chromium.Dr sent me to (b)(6) for mri done on (b)(6) 2013.Report showed significant magnetic susceptivity arising from left hip arthroplasty.Also fluid collection along the greater trochanter.Dr.Felt a left hip revision may be needed.Sent to dr.(b)(6) for 2 opinion.He agreed with dr (b)(6).Left hip revision was done on (b)(6) 2014 at (b)(6).Had staples removed on (b)(6) 2014.That night went to er; fluid coming out of incision.Sent home after blood was draws.Results never communicated to me nor by dr next day.Wbc was 14.7.On (b)(6) 2014, saw dr.In office, scheduled surgery 1st thing next day because on infection on left hip.Never would have had an infection if i had never needed the revision surgery.

• Brand Name: ACETABULAR SYSTEM
• Type of Device: ACETABULAR
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 5096381
• MDR Text Key: 26589671
• Report Number: MW5056353
• Device Sequence Number: 4
• Product Code: KWB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00875705002
• Device Catalogue Number: 00875705002
• Device Lot Number: 61705388
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LOW DOSE ASPIRIN
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 132