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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. UNKN R3 SHELL PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Dislocation (2374)
Event Date 07/26/2013
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4). Lee, p. Y. , & evans, a. R. (2014). Early failure of the polarstem total hip arthroplasty¿can the australian njr tell us the full story?. The journal of arthroplasty, 29(3), 609-611. Doi: http://dx. Doi. Org/10. 1016/j. Arth. 2013. 07. 040.
 
Event Description
It was reported that on literature review "early failure of the polarstem total hip arthroplasty¿can the australian njr tell us the full story?", two (2) patients who initially underwent primary thr implantation with a combination of a cementless collared polarstem and an r3 acetabular cup, experienced a postoperative dislocation that required a close reduction and bracing. The outcome of these patients is unknown. No further information is available.
 
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Brand NameUNKN R3 SHELL
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
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 Key14711178
MDR Text Key294779385
Report Number1020279-2022-03009
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/19/2022
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 Initial

Patient Treatment Data
Date Received: 06/16/2022 Patient Sequence Number: 1
Treatment
UNKN. POLARSTEM CEMENTLESS (TI/HA)
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