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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71335758
Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Patient Problems Pain (1994); Discomfort (2330); Injury (2348)
Event Date 07/10/2018
Event Type  Injury  
Event Description
It was reported that left hip revision surgery was performed due to multiple dislocations and subluxation episodes causing pain and discomfort.
 
Manufacturer Narrative
Correction: brand name,common device name, manufacturer name, city and state, and concomitant medical products additional information:operator of device, mfr site, report source, date rec¿d by mfr.
 
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Brand Name
R3 20 DEG XLPE ACET LNR 36MM X 58MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
spa park
memphis TN 38116
MDR Report Key8954644
MDR Text Key156280715
Report Number3005975929-2019-00311
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
PMA/PMN Number
K113848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71335758
Device Lot Number13EMD6380
Was Device Available for Evaluation? No
Date Manufacturer Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ACETABULAR SHELL, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; PART NUMBER 71306615 / LOT NUMBER 12KM00711; PART NUMBER 71332525 / LOT NUMBER 13DM20055; PART NUMBER 71335558 / LOT NUMBER 13EM13290; PART NUMBER 71336500 / LOT NUMBER 13DM09000; ACETABULAR SHELL, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
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