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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. UNKN FEMORAL HEAD IMPL PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number UNKNOWN
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Fall (1848); Joint Dislocation (2374)
Event Date 10/07/2017
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: case-(b)(4). Teoh, k. H. , whitham, r. D. , golding, d. M. , wong, j. F. , lee, p. Y. , & evans, a. R. (2018). R3 cup does not have a high failure rate in conventional bearings: a minimum of 5-year follow-up. The journal of arthroplasty, 33(2), 460-463. Doi: https://doi. Org/10. 1016/j. Arth. 2017. 09. 059.
 
Event Description
It was reported that, on the literature review "r3 cup does not have a high failure rate in conventional bearings: a minimum of 5-year follow-up", one (1) patient who underwent revision surgery of the uncemented polarstem due to a periprosthetic femoral fracture experienced a fall and the hip dislocated two (2) times after this revision. As the dislocation was irreducible, she required an open reduction with revision of the r3 acetabular cup to a two (2) mm upsized cup from the same family to accomodate a larger femoral head for increased stability. The patient's outcome is unknown. No further information is available.
 
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Brand NameUNKN FEMORAL HEAD IMPL
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 Key14711217
MDR Text Key294870139
Report Number1020279-2022-03012
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 08/10/2022
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 Received07/20/2022
Was Device Evaluated by Manufacturer? No
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 R3 SHELL
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