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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120152
Device Problems Corroded (1131); Insufficient Information (3190)
Patient Problems Pain (1994); Toxicity (2333); Injury (2348); No Code Available (3191)
Event Date 01/12/2017
Event Type  Injury  
Event Description
It was reported a revision surgery from the left hip was performed due to consistent worsening pain, difference in leg length, metallosis, and corrosion.
 
Manufacturer Narrative
It was reported that left hip revision surgery was performed.During the revision, the acetabular cup, hemi head & modular sleeve were removed.The stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.The reported metallosis, pain, elevated cobalt and chromium levels, lysis, necrosis, and corrosion are consistent with findings associated with metal debris; however, the root cause of the reported clinical reactions cannot be confirmed.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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.Additional information: age or date of birth, brand name, concomitant medical products and device manufacture date.
 
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Brand Name
ACETLR CUP HAP 52MM W/ IMPTR
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key8248757
MDR Text Key133094167
Report Number3005975929-2019-00020
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2013
Device Catalogue Number74120152
Device Lot Number094350
Was Device Available for Evaluation? No
Date Manufacturer Received01/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ANTHOLOGY STEM 71356104/ 08DM06598; HEMI HEAD 74122546/ 08GW18074; MODULAR SLEEVE 74222200/ 09GW24203; UNKNOWN ANTHOLOGY STEM; UNKNOWN BHR DEVICE UNKNOWN LOT; UNKNOWN ANTHOLOGY STEM; UNKNOWN BHR DEVICE UNKNOWN LOT
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age63 YR
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