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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET/ZIMMER, INC. BIOLOX DELTA, CERAMIC FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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ZIMMER BIOMET/ZIMMER, INC. BIOLOX DELTA, CERAMIC FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Catalog Number 00877503601
Patient Problems Pain (1994); Scar Tissue (2060); Distress (2329); Unspecified Tissue Injury (4559)
Event Date 06/16/2021
Event Type  Injury  
Event Description
Pinnacle litigation record received.Patient alleges elevated metal ion resulting in injury, suffered additional scar tissue formation, pain, tissue destruction, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, emotional trauma and distress, and physical disabilities.Mri (magnetic resonance imaging) findings on (b)(6) 2022 describe left hip arthrosis with marginal ridging chondral thinning and degeneration signal changes in the acetabulum, there is mild left trochanteric bursitis.Lateral images demonstrate diffuse attenuation, abnormal signal and tearing of the left anterior superior to the posterior superior labrum.The following competitor implants were placed at the time.Reference report: mw5145689, mw5145690.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
BIOLOX DELTA, CERAMIC FEMORAL HEAD
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Manufacturer (Section D)
ZIMMER BIOMET/ZIMMER, INC.
MDR Report Key17756519
MDR Text Key323626525
Report NumberMW5145688
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 09/13/2023
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
Device Catalogue Number00877503601
Device Lot Number2916775
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/14/2023
Patient Sequence Number1
Treatment
ACETABULAR LINER.; OSSEOTI ACETABULAR SHELL.
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