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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN MOM HIP RESURFACING PROTHESIS; HIP ARTHROPLASTY
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BIOMET UK LTD. UNKNOWN MOM HIP RESURFACING PROTHESIS; HIP ARTHROPLASTY Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
Information received based on journal article entitled limited need for screening of metal-on-metal hip resurfacing patients beyond 10 years of follow-up by walter van der weegen, henk hoekstra, koen brakel and thea sijbesma (2020).Background: national and international guidelines lack consistency on how to screen metal-on-metal (mom) hip arthroplasty patients for adverse reactions to metal debris (armd).Long-term outcomes of mom hip arthroplasty are scarce, hindering further development of such guidelines.We present the clinical, radiological and armd status of 158 cases of hip resurfacing with >10 years follow-up.Methods: a prospective analysis of a cohort of 298 consecutive hip resurfacing procedures was performed at a single institution.All patients underwent mars-mri scanning for pseudotumour screening at least once, regardless of symptoms.Implant survival and reasons for revision were analysed for all patients.Clinical, radiological and mars-mri results were analysed for 158 unrevised procedures with >10 years follow-up.Results: the implant survival was 85.9% at 14.5 years (95% ci, 81.9¿90.6) with revision for all causes as endpoint and 92.3% with mom disease-related revisions excluded (95% ci, 88.2¿95.0).Of the 158 cases with >10 years follow-up, 1 had elevated metal ion levels, 29 had a stable c1 pseudotumour and 6 a stable c2 pseudotumour.All pseudotumours were observed within 3 years after initiating our intensified armd screening (2011), with no new pseudotumours observed after that period.Conclusions: we suggest that follow-up of mom hip resurfacing patients beyond 10 years after surgery can be done with large intervals (i.E.Every 5 years), and only earlier if a patient becomes symptomatic.An overview of the 298 cases, identified that 17 patients were deceased and 36 were revised.Of these 36 revisions, 8 revisions reported due to fracture of the femoral neck (mean time to revision 10.9 months, min¿max: 0¿64 months).This complaint reports the 8 revisions due to fracture of the femoral neck.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.G3: report source, foreign - event occurred in netherlands.Biomet uk ltd have attempted to contact the journal article author, however, the author has informed that no further information is available.The product has not been returned to biomet uk ltd for evaluation, therefore, a thorough investigation has not been possible.We have not been provided with x-rays or any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Trend analysis could not be performed as product numbers are not available.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
 
Event Description
Information received based on journal article entitled limited need for screening of metal-on-metal hip resurfacing patients beyond 10 years of follow-up by walter van der weegen, henk hoekstra, koen brakel and thea sijbesma (2020).Background: national and international guidelines lack consistency on how to screen metal-on-metal (mom) hip arthroplasty patients for adverse reactions to metal debris (armd).Long-term outcomes of mom hip arthroplasty are scarce, hindering further development of such guidelines.We present the clinical, radiological and armd status of 158 cases of hip resurfacing with >10 years follow-up.Methods: a prospective analysis of a cohort of 298 consecutive hip resurfacing procedures was performed at a single institution.All patients underwent mars-mri scanning for pseudotumour screening at least once, regardless of symptoms.Implant survival and reasons for revision were analysed for all patients.Clinical, radiological and mars-mri results were analysed for 158 unrevised procedures with >10 years follow-up.Results: the implant survival was 85.9% at 14.5 years (95% ci, 81.9¿90.6) with revision for all causes as endpoint and 92.3% with mom disease-related revisions excluded (95% ci, 88.2¿95.0).Of the 158 cases with >10 years follow-up, 1 had elevated metal ion levels, 29 had a stable c1 pseudotumour and 6 a stable c2 pseudotumour.All pseudotumours were observed within 3 years after initiating our intensified armd screening (2011), with no new pseudotumours observed after that period.Conclusions: we suggest that follow-up of mom hip resurfacing patients beyond 10 years after surgery can be done with large intervals (i.E.Every 5 years), and only earlier if a patient becomes symptomatic.An overview of the 298 cases, identified that 17 patients were deceased and 36 were revised.Of these 36 revisions, 8 revisions reported due to fracture of the femoral neck (mean time to revision 10.9 months, min¿max: 0¿64 months).This complaint reports the 8 revisions due to fracture of the femoral neck.
 
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Brand Name
UNKNOWN MOM HIP RESURFACING PROTHESIS
Type of Device
HIP ARTHROPLASTY
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key10086422
MDR Text Key200397651
Report Number3002806535-2020-00258
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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