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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREADED HOLE COVER PROSTHESIS HIP SEMI-CONSTRAINED UNCMNTD METAPOLYMERPOROUS

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SMITH & NEPHEW, INC. REF THREADED HOLE COVER PROSTHESIS HIP SEMI-CONSTRAINED UNCMNTD METAPOLYMERPOROUS Back to Search Results
Catalog Number 71336500
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 09/21/2017
Event Type  Injury  
Manufacturer Narrative
The associated complaint devices were returned and evaluated. A clinical investigation concluded that this complaint reports a revision approximately sixteen days post implantation due to loosening. There are no supporting clinical documents available. However, it was reported that the patient had poor bone stock and the cup shifted. The patient impact beyond the revision surgery is unknown, as there is no report of the patient¿s current condition or how the procedure was tolerated. A lab analysis revealed scratches and damage on the returned oxinium femoral head and the returned r3 liner. A review of complaint history did not reveal additional complaints for the listed batches. A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident. Based on the lack of information, the exact root cause for the loosening cannot be determined. A thorough clinical assessment cannot be performed. At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture. Based on this investigation, the need for corrective action is not indicated. No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary. Should additional information be received, the complaint will be reopened.
 
Event Description
It was reported that the doctor revised the acetabular shell on the patient. It was removed the liner, hole cover, shell and femoral head. The patient had poor bone stock and the cup shifted.
 
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Brand NameREF THREADED HOLE COVER
Type of DevicePROSTHESIS HIP SEMI-CONSTRAINED UNCMNTD METAPOLYMERPOROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
markus poettker
1450 brooks road
memphis, TN 38116
MDR Report Key6942451
MDR Text Key109147548
Report Number1020279-2017-00858
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71336500
Device Lot Number17GM14779
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2017
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: 10/11/2017 Patient Sequence Number: 1
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