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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED UNKNOWN HIP FEMORAL HEAD
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FINSBURY ORTHOPAEDICS LIMITED UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Corroded (1131); Naturally Worn (2988)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Event Date 02/01/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Email notification from stryker received.It was reported that the patient had undergone a revision surgery due to disassociation of the head and the stem, trunnion failure, tissue staining and metallois and modular lfit head showed severe wear of the bearing surface as well as extensive erosion and fretting corrosion in the taper and trunnion fracture.Doi: unknown dor: (b)(6) 2019 unknown hip.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand Name
UNKNOWN HIP FEMORAL HEAD
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
FINSBURY ORTHOPAEDICS LIMITED
13 mole business park, randall
leatherhead, surrey KT22 7BA
UK  KT22 7BA
MDR Report Key10283574
MDR Text Key199116443
Report Number1818910-2020-16050
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Date Manufacturer Received08/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
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