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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE HA CTD ACET SHELL 48MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. R3 0 HOLE HA CTD ACET SHELL 48MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Catalog Number 71332248
Device Problem Malposition of Device (2616)
Patient Problem Injury (2348)
Event Date 09/16/2019
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to the cup being in an incorrect position and causing a squeaking with the ceramic hip.
 
Manufacturer Narrative
It was reported that a revision surgery was performed due to the cup being in an incorrect position and causing a squeaking with the ceramic hip.The affected r3 acetabular shell, r3 delta ceramic liner, synergy high offset stem and biolox delta head, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Possible causes could include but not limited to size of device or alignment of implants.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.
 
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Brand Name
R3 0 HOLE HA CTD ACET SHELL 48MM
Type of Device
PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9191589
MDR Text Key162298733
Report Number1020279-2019-03657
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71332248
Device Lot Number15BM08001
Date Manufacturer Received02/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PART NUMBER 71309111 / LOT NUMBER 14KM15087; PART NUMBER 71331748 / LOT NUMBER 14AT38941; PART NUMBER 71336500 / LOT NUMBER 14MM16877; PART NUMBER 76539160 / LOT NUMBER 14ET42301; PART NUMBER 71309111 / LOT NUMBER 14KM15087; PART NUMBER 71331748 / LOT NUMBER 14AT38941; PART NUMBER 71336500 / LOT NUMBER 14MM16877; PART NUMBER 76539160 / LOT NUMBER 14ET42301
Patient Outcome(s) Hospitalization; Required Intervention;
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