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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY) PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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SMITH & NEPHEW ORTHOPAEDICS AG UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY) PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Catalog Number UNKN1102901
Device Problem Loss of Osseointegration (2408)
Patient Problem Failure of Implant (1924)
Event Date 01/01/1901
Event Type  Injury  
Event Description
On the literature article named "spinopelvic alignment does not change after bilateral total hip arthroplasty in patients with bilateral crowe type-iv developmental dysplasia of the hip", it was reported that a patient underwent a revision surgery of the sl-plus family stem due to instability, loosening and subsequent nonunion of the stem at the osteotomy site at the distant end of the trochanter minor. The outcome of the patient is unknown.
 
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Brand NameUNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY)
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ CH-5000
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ CH-5000
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11992833
MDR Text Key256035139
Report Number9613369-2021-00292
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKN1102901
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/14/2021 Patient Sequence Number: 1
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