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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BIOLOX DELTA CE BALL HEAD 12/14 36L; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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SMITH & NEPHEW ORTHOPAEDICS AG BIOLOX DELTA CE BALL HEAD 12/14 36L; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Catalog Number 75007450
Device Problems Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Failure of Implant (1924)
Event Date 08/18/2009
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, after a thr surgery performed on (b)(6) 2009, a revision surgery was performed on (b)(6) 2009 due to irritation between the biolox delta ce ball head 12/14 36l and the ep-fit/mpf ceramic insert delta 52/32.Later on (b)(6) 2021, patient underwent another revision surgery due to a fracture of the nanos stem.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, after a thr surgery performed on (b)(6) 2009, a revision surgery was performed on (b)(6) 2009 due to irritation between the biolox delta ce ball head 12/14 36l and the ep-fit/mpf ceramic insert delta 52/32.Later on (b)(6) 2021, patient underwent another revision surgery due to a fracture of the nanos stem.
 
Manufacturer Narrative
(b)(4).H6: updated medical device problem code.
 
Manufacturer Narrative
Results of investigation: it was reported that, after a thr surgery performed on 20-jan-2009, a revision surgery was performed on (b)(6) 2009 due to irritation between the biolox delta ce ball head 12/14 36l and the ep-fit/mpf ceramic insert delta 52/32.Since the revision took place in 2009, the devices, used in treatment were no returned for investigation.Therefore, the relationship between the reported event and the device cannot be confirmed.The production documentation of both devices was reviewed.There are no indications that the device failed to match specification at the time of manufacturing.The complaint history of the devices was reviewed.The risk profile of both devices is low and covered through the corresponding risk management files.The current ifu lists several potential adverse events and medical device problems which could have led or describe the discomfort / irritation at the insert/ball head interface.Review of past corrective actions was performed.No further escalation is required.Based on the provided information a medical assessment was conducted.The provided x-rays do not contribute to the root cause of the squeaking but it¿s a known symptom with a ceramic on ceramic articulation.With the information provided the clinical root cause of the ¿irritation and squeaking¿ cannot be confirmed, and it cannot be concluded that the reported events were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Based on the available information the root cause stays undetermined after investigation.It cannot be speculated about contributing factors.To date, the need for further investigation is not indicated.Smith and nephew will monitor this device for further similar issues.
 
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Brand Name
BIOLOX DELTA CE BALL HEAD 12/14 36L
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ  CH-5000
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ   CH-5000
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13310609
MDR Text Key285427231
Report Number9613369-2022-00009
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/07/2015
Device Catalogue Number75007450
Device Lot NumberA0808869
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/08/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
75003896-EP-FIT PLUS SHELL TI-PLASMA 60 NON-CEM; 75008160-NANOS FEMORAL NECK PROSTHESIS NONCEM 6
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age82 YR
Patient SexMale
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