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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. UNKN R3 IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number UNKN01100900
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thromboembolism (2654)
Event Date 08/01/2009
Event Type  Injury  
Event Description
*literature case* "mid-term clinical results of the cementless r3 cup and polarstem total hip arthroplasty".Author: ali assaf et al., european journal of orthopaedic surgery & traumatology (2019).It was documented on the paper that there was a patient who developed a thromboembolic event.The patient had a deep venous thrombosis in the operated limb in the third week post-operatively.The patient was receiving oral anticoagulation therapy as per hospital protocol.
 
Manufacturer Narrative
It was reported from a literature review that the patient had a deep venous thrombosis in the operated limb in the third week post-operatively.The patient was receiving oral anticoagulation therapy as per hospital protocol.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Some potential causes of the reported event could include but not limited to patient medical conditions, surgical technique or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
 
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Brand Name
UNKN R3 IMPLANT
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10230750
MDR Text Key197554837
Report Number1020279-2020-02915
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
PMA/PMN Number
K070756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/09/2020
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? No
Device Operator Health Professional
Device Catalogue NumberUNKN01100900
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/15/2020
Initial Date FDA Received07/03/2020
Supplement Dates Manufacturer Received09/21/2020
Supplement Dates FDA Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN FEMORAL HEAD; UNKNOWN LINER; UNKNOWN POLARSTEM
Patient Outcome(s) Life Threatening;
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