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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN ORTHOPAEDIC RECONSTRUCTION DEV PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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SMITH & NEPHEW ORTHOPAEDICS AG UNKN ORTHOPAEDIC RECONSTRUCTION DEV PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number UNKN01000000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Dislocation (2374)
Event Date 03/05/2021
Event Type  Injury  
Event Description
Polar3. Hip. Pro. 2019. 02; subject 12. 012; ae 01. It was reported that after a bilateral tha performed on (b)(6) 2021, the patient suffered from a dislocation on (b)(6) 2021. Manual repositioning was performed. The causal relationship and severity have not been determined as of today.
 
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Brand NameUNKN ORTHOPAEDIC RECONSTRUCTION DEV
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ CH-5000
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11593541
MDR Text Key243127613
Report Number9613369-2021-00132
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K113848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/26/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKN01000000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/30/2021 Patient Sequence Number: 1
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