SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
|
Back to Search Results |
|
Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Osteolysis (2377)
|
Event Date 07/21/2021 |
Event Type
Injury
|
Event Description
|
It was reported that, on literature review "results of the first u.S fda - approved hip resufacing device at 10 - year follow - up.", osteolysis was identified in seven (7) out of two hundred eighteen (218) acetabular components implanted on patients who underwent primary surgery with a bhr resurfacing construct.Although it is unknown how this event was addressed on each patient, a revision surgery was not required.Further information was not provided.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).Su, e.P., ho, h., bhal, v., housman, l.R., masonis, j.L., noble jr, j.W.,.& engh jr, c.A.(2021).Results of the first us fda-approved hip resurfacing device at 10-year follow-up.Jbjs, 103(14), 1303-1311.Doi: 10.2106/jbjs.20.01886.
|
|
Manufacturer Narrative
|
H3, h6: it was reported that, on literature review "results of the first u.S fda - approved hip resufacing device at 10 - year follow - up.", osteolysis was identified in seven out of two hundred eighteen acetabular components implanted on patients who underwent primary surgery with a bhr resurfacing construct.Although it is unknown how this event was addressed on each patient, a revision surgery was not required.Therefore, the devices, used in treatment, could not be analysed.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.A risk management review was performed for the acetabular cup.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
|
|
Search Alerts/Recalls
|
|
|