MCOR FEMORAL STEM 1-820-070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-18 for MCOR FEMORAL STEM 1-820-070 manufactured by Zimmer Biomet.

Event Text Entries

[26589671] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5056353
• MDR Report Key: 5096381
• Date Received: 2015-09-18
• Date of Event: 2011-11-18
• Date Added to Maude: 2015-09-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MCOR FEMORAL STEM
• Generic Name: FEMORAL STEM
• Product Code: KWY
• Date Received: 2015-09-18
• Model Number: 1-820-070
• Catalog Number: 1-820-070
• Lot Number: 3338
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET

Device Sequence Number: 2

• Brand Name: BIOLOX DELTA FEMORAL HEAD
• Generic Name: CERAMIC FEMORAL HEAD
• Product Code: LZO
• Date Received: 2015-09-18
• Model Number: 00-8775-036-02
• Catalog Number: 00-8775-036-02
• Lot Number: 2597820
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET

Device Sequence Number: 3

• Brand Name: MCOR FEMORAL NECK
• Generic Name: FEMORAL NECK
• Product Code: KWY
• Date Received: 2015-09-18
• Model Number: 1-8-25-039
• Catalog Number: 1-8-25-039
• Lot Number: E01111701
• Device Expiration Date: 2016-03-01
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET

Device Sequence Number: 4

• Brand Name: ACETABULAR SYSTEM
• Generic Name: ACETABULAR
• Product Code: KWB
• Date Received: 2015-09-18
• Model Number: 00875705002
• Catalog Number: 00875705002
• Lot Number: 61705388
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET

Device Sequence Number: 5

• Brand Name: BONE SCREWS
• Generic Name: BONE SCREWS
• Product Code: HWC
• Date Received: 2015-09-18
• Model Number: 62506540
• Catalog Number: 62506540
• Lot Number: 61825119
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET

Device Sequence Number: 6

• Brand Name: BONE SCREW
• Generic Name: BONE SCREW
• Product Code: HWC
• Date Received: 2015-09-18
• Model Number: 62506535
• Catalog Number: 62506535
• Lot Number: 61760636
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET

Device Sequence Number: 7

• Brand Name: TRILOGY ALLOFIT IT ACETABULAR SYSTEM
• Generic Name: ACETABULAR
• Product Code: LPH
• Date Received: 2015-09-18
• Model Number: 00-8770-009-34
• Catalog Number: 00-8770-009-34
• Lot Number: 2517925
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET

Device Sequence Number: 8

• Brand Name: BIOLOX OPTION FEMORAL HEAD
• Generic Name: FEMORAL HEAD ADAPTER
• Product Code: LZO
• Date Received: 2015-09-18
• Model Number: 170-32-50
• Catalog Number: 170-32-50
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 8
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET

Device Sequence Number: 9

• Brand Name: BIOLOX OPTION ADAPTOR
• Generic Name: ADAPTOR
• Product Code: LZO
• Date Received: 2015-09-18
• Model Number: 170-50-00
• Catalog Number: 170-50-00
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 9
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET

Device Sequence Number: 10

• Brand Name: CONTINUUM ACETABULAR SYSTEM
• Generic Name: ACETABULAR SYSTEM
• Product Code: LPH
• Date Received: 2015-09-18
• Model Number: 00-8851-009-32
• Catalog Number: 00-8851-009-32
• Lot Number: 620164638
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 10
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention	2015-09-18