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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
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SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Back to Search Results
Model Number 74122546
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiomyopathy (1764); Injury (2348); Renal Impairment (4499); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Event Date 01/02/2010
Event Type  Injury  
Event Description
It was reported that left hip revision surgery was performed due to infection.The head and the sleeve were explanted.
 
Manufacturer Narrative
It was reported that a left hip revision surgery was performed.Hemi head and modular sleeve were revised.The devices involved were all used in treatment.As of today additional information have been requested for this complaint but have not become available.A review of the complaint history for the head and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.It was also confirmed that all devices were sterilised.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.The reported drainage, fever, elevated wbc¿s, crp, esr and intraoperative findings of pus and pseudocapsule may be consistent with infection; however, the root cause of the infection cannot be confirmed.It should be noted the patient¿s diagnosis of sepsis 3 months prior to this revision cannot be ruled out as a contributing factor to his left hip pain, sepsis and subsequent revision.The infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.The patient impact beyond infection, revision and expected transient post op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.
 
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Brand Name
HEMI HEAD 46MM
Type of Device
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key10331807
MDR Text Key200588540
Report Number3005975929-2020-00270
Device Sequence Number1
Product Code KWL
UDI-Device Identifier00885556071588
UDI-Public00885556071588
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number74122546
Device Catalogue Number74122546
Device Lot Number08EW17157
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/06/2020
Initial Date FDA Received07/28/2020
Supplement Dates Manufacturer Received12/12/2020
Supplement Dates FDA Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
74222100 / 07FW12475 - MODULAR SLEEVE -4 MM 12/14; 74222100 / 07FW12475 - MODULAR SLEEVE -4 MM 12/14
Patient Outcome(s) Hospitalization; Required Intervention;
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