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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE HUMERAL BEARING LINER SELF CA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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STANMORE IMPLANTS WORLDWIDE HUMERAL BEARING LINER SELF CA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Catalog Number HBLSC
Device Problem Naturally Worn (2988)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
The reported device is similar to a device approved for compassionate use in the united states.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
A patient specific implant request form was received for the patient's right shoulder.Noted on the form: "complex background over many years resulting in right bw with custom humeral stem in 2012.Subsequent wearing of liner due to heavy use (using machinery), resulting in revision of liner in 2020.No problems ever with fixation of either humeral stem or glenoid screw." this pi is for the 2020 revision.
 
Event Description
A patient specific implant request form was received for the patient's right shoulder.Noted on the form: "complex background over many years resulting in right bw with custom humeral stem in 2012.Subsequent wearing of liner due to heavy use (using machinery), resulting in revision of liner in 2020.No problems ever with fixation of either humeral stem or glenoid screw." this pi is for the 2020 revision.
 
Manufacturer Narrative
The reported device is similar to a device approved for compassionate use in the united states.Reported event: an event regarding wear involving a mets, total shoulder (bayley/walker) replacement, liner was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, additional pre and post-surgery x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
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Brand Name
HUMERAL BEARING LINER SELF CA
Type of Device
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK  WD6 3SJ
Manufacturer (Section G)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK   WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key15787393
MDR Text Key303541583
Report Number3004105610-2022-00159
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2017
Device Catalogue NumberHBLSC
Device Lot NumberB10128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
Patient SexMale
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