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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET/ZIMMER, INC. G7 OSSEOTI ACETABULAR SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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ZIMMER BIOMET/ZIMMER, INC. G7 OSSEOTI ACETABULAR SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 110010244
Patient Problems Pain (1994); Scar Tissue (2060); Distress (2329); Unspecified Tissue Injury (4559)
Event Type  Other  
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: mw5145688, 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
G7 OSSEOTI ACETABULAR SHELL
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
ZIMMER BIOMET/ZIMMER, INC.
MDR Report Key17756560
MDR Text Key323631179
Report NumberMW5145689
Device Sequence Number1
Product Code LPH
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? No
Is this a Product Problem Report? No
Device Catalogue Number110010244
Device Lot Number6424103
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/14/2023
Patient Sequence Number1
Treatment
BIOLOX DELTA, CERAMIC FEMORAL HEAD; G7 ACETABULAR LINER
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