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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CON LNR 0DEG 26ID 50-52OD SZ E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
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SMITH & NEPHEW, INC. CON LNR 0DEG 26ID 50-52OD SZ E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER Back to Search Results
Model Number 71323114
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 07/20/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that after a thr performed on (b)(6) 2021, it was reported that a patient experimented a dislocation of the implant.A revision surgery took place on (b)(6) 2021 to evaluate the best way to fix the problem and the acetabular cup and liner were replaced with another company's implants.New smith and nephew femoral head implanted.It is unknown how femoral head was able to dislocate out of constrained liner.Patient condition is unknown.
 
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Brand Name
CON LNR 0DEG 26ID 50-52OD SZ E
Common Device Name
PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key12294329
Report Number1020279-2021-06226
Device Sequence Number11683112
Product Code KWZ
UDI-Device Identifier03596010510884
UDI-Public03596010510884
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K033442
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/03/2021
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? Yes
Operator of Device Health Professional
Device Model Number71323114
Device Catalogue Number71323114
Device Lot Number18BM17863
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/20/2021
Supplement Date Received by Manufacturer09/01/2021
Initial Report FDA Received Date08/09/2021
Supplement Report FDA Received Date09/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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